Authorized representative profile
PT. ANDAMAN MEDICAL INDONESIA
Indonesia·279 products represented·87 manufacturersRegistered address
- Address
- Menara Cardig Lantai 1, Jalan Raya Halim Perdanakusuma
279
Total Products
87
Manufacturers
3
Product Classes
4
Risk Classes
Risk classification breakdown
Distribution of represented products across risk classes
Kelas Resiko : A
39
14.0% of total
Kelas Resiko : B
87
31.2% of total
Kelas Resiko : C
117
41.9% of total
Kelas Resiko : D
36
12.9% of total
Manufacturer portfolio
Products organized by manufacturer
L&K BIOMED CO., LTD.
30 ProductsKorea
LnK Spinal Instrument System - Surgical Drill HandpieceDec 6, 2019
Kelas Resiko : A
LnK Spinal Instrument SystemDec 6, 2019
Kelas Resiko : A
OPENLOC-L Spinal Fixation SystemFeb 27, 2019
Kelas Resiko : C
OPENLOC-L Spinal Fixation SystemFeb 27, 2019
Kelas Resiko : C
OPENLOC-L Spinal Fixation SystemFeb 26, 2019
Kelas Resiko : C
View all 30 products from this manufacturer →DIAMED GMBH
20 ProductsSwitzerland
BIO-RAD ID-DiaPanel-PNov 11, 2024
Kelas Resiko : C
BIO-RAD ID-Dia (Diego) PositiveNov 9, 2024
Kelas Resiko : C
BIO-RAD ID-DiaCell ABO A1, BNov 9, 2024
Kelas Resiko : C
BIO-RAD DiaClon RhD + PhenotypeNov 9, 2024
Kelas Resiko : C
DIAMED IH-QC7 Modular SystemApr 7, 2023
Kelas Resiko : B
View all 20 products from this manufacturer →12 Products
P Flex Ureteral Stent & SetSep 23, 2024
Kelas Resiko : C
Bluthane Ureteral Stent & SetSep 19, 2024
Kelas Resiko : C
DENSSIFLO PTBD CatheterSep 12, 2024
Kelas Resiko : C
BLUE TAKE GuidewireSep 10, 2024
Kelas Resiko : C
BLUE NEEM Percutaneous Nephrostomy Drainage Set - PigtailSep 6, 2024
Kelas Resiko : C
View all 12 products from this manufacturer →FUJIREBIO EUROPE N.V.
12 ProductsBelgium
INNO-LiPA HPV Genotyping Extra II Amp <20T, CE>Jul 9, 2024
Kelas Resiko : C
INNO-LiPA HPV Genotyping Extra II <20T,CE>Jul 9, 2024
Kelas Resiko : C
INNO-LIA HIV I/II ScoreApr 22, 2024
Kelas Resiko : D
INNOTEST β-AMYLOID(1-40)Feb 13, 2024
Kelas Resiko : B
INNOTEST PHOSPHO-TAU (181P)Feb 13, 2024
Kelas Resiko : B
View all 12 products from this manufacturer →SONOVA AT
10 ProductsSwitzerland
EDWARDS LIFESCIENCES LLC
9 ProductsUnited States
MITRIS RESILIA Mitral ValveDec 3, 2024
Kelas Resiko : D
INSPIRIS RESILIA Aortic ValveNov 18, 2023
Kelas Resiko : D
Carpentier-Edwards Physio II Annuloplasty RingNov 17, 2023
Kelas Resiko : C
Carpentier-Edwards Physio Annuloplasty RingNov 17, 2023
Kelas Resiko : C
EDWARDS LIFESCIENCES Annuloplasty Rings Accessories Sizers Use with models 4500, 4600, 4900, 6200Nov 13, 2023
Kelas Resiko : A
View all 9 products from this manufacturer →DIAMED GMBH.
9 ProductsSwitzerland
DIAMED IH-QC5 Modular SystemMar 15, 2023
Kelas Resiko : B
ID- Titration SolutionFeb 8, 2023
Kelas Resiko : A
DiaClon ABD-Confirmation for PatientsJan 25, 2023
Kelas Resiko : C
DIAMED Coombs Anti-IgGJan 25, 2023
Kelas Resiko : B
ID-DiaClon Anti-DJan 25, 2023
Kelas Resiko : C
View all 9 products from this manufacturer →RADIOMETER MEDICAL APS
8 ProductsDenmark
ABL90 Sensor Cassette SC90 Ki BG, LYT, MET, UREA, CREA, OXI + QCOct 21, 2024
Kelas Resiko : C
ABL90 Sensor Cassette SC90 BG, LYT, OXI + QCOct 14, 2024
Kelas Resiko : B
ABL90 Sensor Cassette SC90 BG, LYT, MET, OXI + QCOct 11, 2024
Kelas Resiko : B
ABL90 Sensor Cassette SC90 BG, LYT, MET, Hb + QCOct 11, 2024
Kelas Resiko : B
ABL90 Solution Pack KiOct 9, 2024
Kelas Resiko : B
View all 8 products from this manufacturer →INVENTIS S.R.L
8 ProductsItaly
INVENTIS Middle Ear Analyzer Clarinet PlusApr 2, 2024
Kelas Resiko : B
INVENTIS Piccolo SpeechApr 2, 2024
Kelas Resiko : B
INVENTIS Portable Audiometer Piccolo Speech AeroSep 6, 2019
Kelas Resiko : B
INVENTIS Piccolo PlusSep 6, 2019
Kelas Resiko : B
INVENTIS Portable Audiometer Piccolo Basic AeroSep 6, 2019
Kelas Resiko : B
View all 8 products from this manufacturer →8 Products
BLOOD Panty Pads 50cm (L-XL)Nov 13, 2023
Kelas Resiko : A
BLOOD Sanitary Pads 41 cmNov 13, 2023
Kelas Resiko : A
BLOOD Panty Pads 50cm (M-L)Apr 21, 2022
Kelas Resiko : A
BLOOD Panty Pads 50cm (S-M)Apr 21, 2022
Kelas Resiko : A
BLOOD Sanitary Pads 15 cm (Liner)Apr 20, 2022
Kelas Resiko : A
View all 8 products from this manufacturer →ON-X LIFE TECHNOLOGIES, INC.
7 ProductsUnited States
ON-X Ascending Aortic Prosthesis with the Vascutek Gelweave Valsalva GraftJan 13, 2025
Kelas Resiko : D
On-X Aortic Prosthetic Heart Valve - Anatomic Sewing Ring, Extended HolderDec 10, 2023
Kelas Resiko : D
On-X® Prosthetic Heart Valve InstrumentsDec 4, 2023
Kelas Resiko : A
ON-X® Conform-X® Aortic Prosthetic Heart Valve – Extended HolderDec 4, 2023
Kelas Resiko : D
On-X Aortic Prosthetic Heart Valve – Extended HolderNov 18, 2023
Kelas Resiko : D
View all 7 products from this manufacturer →BIO-RAD
7 ProductsFrance
MONOLISA HBs Ag ULTRAJun 19, 2023
Kelas Resiko : D
MONOLISA HCV Ag-Ab ULTRA V2Feb 22, 2023
Kelas Resiko : D
GEENIUS™ Reader and AccessoriesJan 26, 2023
Kelas Resiko : A
Geenius™ HIV 1/2 Confirmatory ControlsJan 25, 2023
Kelas Resiko : B
Geenius™ HCV Supplemental ControlsJan 25, 2023
Kelas Resiko : B
View all 7 products from this manufacturer →INVENTIS S.R.L.
6 ProductsItaly
CELLO AudiometerApr 25, 2024
Kelas Resiko : B
INVENTIS Middle Ear Analyzer ViolaApr 5, 2024
Kelas Resiko : B
INVENTIS Middle Ear Analyzer Flute BasicApr 2, 2024
Kelas Resiko : B
TIMPANI Handheld Tympanometer / Screening AudiometerMar 28, 2024
Kelas Resiko : B
INVENTIS Middle Ear Analyzer Clarinet BasicSep 2, 2019
Kelas Resiko : B
View all 6 products from this manufacturer →SCHOLLY FIBEROPTIC GMBH.
5 ProductsGermany
5 Products
4 Products
4 Products
VERSAH LLC.
4 ProductsUnited States
VUNO INC.
4 ProductsKorea
LAMBDA SPA
4 ProductsItaly
OWEN MUMFORD SDN BHD
4 ProductsMalaysia
4 Products
TRELLEBORG SEALING SOLUTIONS US, INC.
3 ProductsUnited States
BIO-RAD (STEENVOORDE)
3 ProductsFrance
3 Products
3 Products
WON TECH CO., LTD.
3 ProductsKorea
MEDIT CORP.
3 ProductsKorea
3 Products
3 Products
PANTHER HEALTHCARE Linear Stapler and Reloading UnitsNov 6, 2023
Kelas Resiko : C
PANTHER HEALTHCARE Linear Cutter Stapler and Reloading Unit for Linear Cutter StaplerNov 10, 2022
Kelas Resiko : C
PANTHER HEALTHCARE Endo Linear Cutter Stapler and Reloading Unit for Endo Linear Cutter StaplerNov 6, 2022
Kelas Resiko : C
EDWARDS LIFESCIENCES AG
3 ProductsDominican
3 Products
AROA BIOSURGERY LTD.
3 ProductsNew Zealand
2 Products
2 Products
2 Products
MASTELLI S.R.L
2 ProductsItaly
HEXACATH
2 ProductsFrance
2 Products
TIMEWAVER PRODUCTION GMBH
2 ProductsGermany
2 Products
1 Products
1 Products
BIO PREVENTIVE MEDICINE CORP.
1 ProductsTaiwan (China)
MEDICAGO AB
1 ProductsSweden
1 Products
1 Products
BIOPANDA REAGENTS LTD
1 ProductsUnited Kingdom
1 Products
EDWARDS LIFESCIENCES LLC.
1 ProductsUnited States
WETLING EU APS.
1 ProductsDenmark
1 Products
EYE TECH CARE
1 ProductsFrance
RED&BLUE CO., LTD.
1 ProductsKorea
ADIPOLABS CO., LTD.
1 ProductsKorea
THE SPINECORPORATION LIMITED
1 ProductsUnited Kingdom
1 Products
EDWARDS LIFESCIENCES COSTA RICA S.R.L
1 ProductsCosta Rica
1 Products
1 Products
1 Products
CROWN AESTHETICS
1 ProductsUnited States
BIOMED LABORATORIES, LLC
1 ProductsUnited States
COGMEDIX
1 ProductsUnited States
STRATEC SE
1 ProductsGermany
STRATEC BIOMEDICAL SWITZERLAND AG
1 ProductsSwitzerland
1 Products
GRANULAB (M) SDN., BHD.
1 ProductsMalaysia
PIKDARE S.R.L,
1 ProductsItaly
BIO-RAD LABORATORIES, INC.
1 ProductsUnited States
1 Products
1 Products
HEALY GMBH
1 ProductsGermany
1 Products
All represented products (279)
Complete portfolio registered with BPOM
NETROD™ Radio Frequency Renal Ablation CatheterFeb 11, 2025
Manufacturer: SHANGHAI GOLDEN LEAF MEDTECH CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
BONEUNION MEDICAL Upper Limb PlateFeb 5, 2025
Manufacturer: BONEUNION (XIAMEN) MEDICAL DEVICE CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
INNOLCON Ultrasonic Surgical SystemJan 30, 2025
Manufacturer: INNOLCON MEDICAL TECHNOLOGY (SUZHOU) CO., LTD. (BUILDING 10)
Class: Kelas : 2
Risk Class: Kelas Resiko : C
NETROD™ Radio Frequency Renal Ablation DeviceJan 22, 2025
Manufacturer: SHANGHAI GOLDEN LEAF MEDTECH CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
PERMEADERM Biosynthetic Wound MatrixJan 19, 2025
Manufacturer: TRELLEBORG SEALING SOLUTIONS US, INC.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
PERMEADERM Biosynthetic Wound MatrixJan 19, 2025
Manufacturer: TRELLEBORG SEALING SOLUTIONS US, INC.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
PHONAK TERRA BTE-MJan 17, 2025
Manufacturer: SONOVA AT
Class: Kelas : 2
Risk Class: Kelas Resiko : B
PHONAK TERRA+ BTE-MJan 17, 2025
Manufacturer: SONOVA AT
Class: Kelas : 2
Risk Class: Kelas Resiko : B
PHONAK TERRA+ BTE-UPJan 17, 2025
Manufacturer: SONOVA AT
Class: Kelas : 2
Risk Class: Kelas Resiko : B
PHONAK TERRA+ RIC-312Jan 17, 2025
Manufacturer: SONOVA AT
Class: Kelas : 2
Risk Class: Kelas Resiko : B
PHONAK NAIDA L50-SPJan 15, 2025
Manufacturer: SONOVA AT
Class: Kelas : 2
Risk Class: Kelas Resiko : B
PHONAK NAIDA L90-SPJan 15, 2025
Manufacturer: SONOVA AT
Class: Kelas : 2
Risk Class: Kelas Resiko : B
PHONAK NAIDA L50-UPJan 14, 2025
Manufacturer: SONOVA AT
Class: Kelas : 2
Risk Class: Kelas Resiko : B
PHONAK NAIDA L90-UPJan 14, 2025
Manufacturer: SONOVA AT
Class: Kelas : 2
Risk Class: Kelas Resiko : B
PHONAK NAIDA L90-PRJan 14, 2025
Manufacturer: SONOVA AT
Class: Kelas : 2
Risk Class: Kelas Resiko : B
ON-X Ascending Aortic Prosthesis with the Vascutek Gelweave Valsalva GraftJan 13, 2025
Manufacturer: ON-X LIFE TECHNOLOGIES, INC.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
PHONAK NAIDA L50-PRJan 9, 2025
Manufacturer: SONOVA AT
Class: Kelas : 2
Risk Class: Kelas Resiko : B
BIO-RAD Monolisa HBs Ag ULTRADec 13, 2024
Manufacturer: BIO-RAD (STEENVOORDE)
Class: Kelas : 3
Risk Class: Kelas Resiko : D
BIO-RAD Genscreen ULTRA HIV Ag-AbDec 5, 2024
Manufacturer: BIO-RAD (STEENVOORDE)
Class: Kelas : 3
Risk Class: Kelas Resiko : D
MITRIS RESILIA Mitral ValveDec 3, 2024
Manufacturer: EDWARDS LIFESCIENCES LLC
Class: Kelas : 3
Risk Class: Kelas Resiko : D
DNlite-DKD uPTM-FetA ELISA KitDec 2, 2024
Manufacturer: BIO PREVENTIVE MEDICINE CORP.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
HUGEMED Flexible Video UreterorenoscopeNov 29, 2024
Manufacturer: SHENZHEN HUGEMED MEDICAL TECHNICAL DEVELOPMENT CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
BIO-RAD Monolisa HCV Ag-Ab Ultra V2Nov 20, 2024
Manufacturer: BIO-RAD (STEENVOORDE)
Class: Kelas : 3
Risk Class: Kelas Resiko : D
INNOLCON Phacoemulsification Surgical SystemNov 19, 2024
Manufacturer: INNOLCON MEDICAL TECHNOLOGY (SUZHOU) CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
UROMEDTECH UROMASTER® ADVENTURENov 14, 2024
Manufacturer: UROMEDTECH PTE LTD
Class: Kelas : 2
Risk Class: Kelas Resiko : B
JULAINENov 13, 2024
Manufacturer: MEDICAGO AB
Class: Kelas : 3
Risk Class: Kelas Resiko : D
BIO-RAD ID-DiaPanel-PNov 11, 2024
Manufacturer: DIAMED GMBH
Class: Kelas : 2
Risk Class: Kelas Resiko : C
BIO-RAD ID-Dia (Diego) PositiveNov 9, 2024
Manufacturer: DIAMED GMBH
Class: Kelas : 2
Risk Class: Kelas Resiko : C
BIO-RAD ID-DiaCell ABO A1, BNov 9, 2024
Manufacturer: DIAMED GMBH
Class: Kelas : 2
Risk Class: Kelas Resiko : C
BIO-RAD DiaClon RhD + PhenotypeNov 9, 2024
Manufacturer: DIAMED GMBH
Class: Kelas : 2
Risk Class: Kelas Resiko : C
CORINA Silicone Rubber Uterine Drug-Eluting Stent SystemNov 3, 2024
Manufacturer: PUYI (SHANGHAI) BIOTECHNOLOGY CO., LTD.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
INNOLCON Phacoemulsification Surgical SystemNov 1, 2024
Manufacturer: INNOLCON MEDICAL TECHNOLOGY (SUZHOU) CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
BIO-RAD Syphilis Total AbOct 28, 2024
Manufacturer: BIO-RAD ( STEENVORDE)
Class: Kelas : 2
Risk Class: Kelas Resiko : C
PROLUS Monofilament PropyleneOct 21, 2024
Manufacturer: TI MEDICAL PRIVATE LIMITED.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
ABL90 Sensor Cassette SC90 Ki BG, LYT, MET, UREA, CREA, OXI + QCOct 21, 2024
Manufacturer: RADIOMETER MEDICAL APS
Class: Kelas : 2
Risk Class: Kelas Resiko : C
SILKUS Braided Coated SilkOct 21, 2024
Manufacturer: TI MEDICAL PRIVATE LIMITED.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
SOLUS Braided Coated Polyglycolic AcidOct 15, 2024
Manufacturer: TI MEDICAL PRIVATE LIMITED
Class: Kelas : 2
Risk Class: Kelas Resiko : C
ABL90 Sensor Cassette SC90 BG, LYT, OXI + QCOct 14, 2024
Manufacturer: RADIOMETER MEDICAL APS
Class: Kelas : 2
Risk Class: Kelas Resiko : B
ABL90 Sensor Cassette SC90 BG, LYT, MET, OXI + QCOct 11, 2024
Manufacturer: RADIOMETER MEDICAL APS
Class: Kelas : 2
Risk Class: Kelas Resiko : B
ABL90 Sensor Cassette SC90 BG, LYT, MET, Hb + QCOct 11, 2024
Manufacturer: RADIOMETER MEDICAL APS
Class: Kelas : 2
Risk Class: Kelas Resiko : B
DODODOTS Acne PatchOct 10, 2024
Manufacturer: WENZHOU CELECARE MEDICAL INSTRUMENTS CO., LTD.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
SOLUS-910 Braided Coated Poly (Glycolide-Co-L-Lactide)/Polyglactin-910Oct 10, 2024
Manufacturer: TI MEDICAL PRIVATE LIMITED
Class: Kelas : 2
Risk Class: Kelas Resiko : C
ABL90 Solution Pack KiOct 9, 2024
Manufacturer: RADIOMETER MEDICAL APS
Class: Kelas : 2
Risk Class: Kelas Resiko : B
ABL90 Solution Pack KiOct 9, 2024
Manufacturer: RADIOMETER SOLUTIONS SP. Z O.O.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
ABL90 FLEX Solution PackOct 9, 2024
Manufacturer: RADIOMETER SOLUTIONS SP. Z O.O.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
ABL90 FLEX Solution PackOct 8, 2024
Manufacturer: RADIOMETER MEDICAL APS
Class: Kelas : 2
Risk Class: Kelas Resiko : B
ABL90 FLEX PLUSOct 7, 2024
Manufacturer: RADIOMETER MEDICAL APS
Class: Kelas : 2
Risk Class: Kelas Resiko : B
NYLUS Monofilament PolyamideOct 7, 2024
Manufacturer: TI MEDICAL PRIVATE LIMITED
Class: Kelas : 2
Risk Class: Kelas Resiko : C
ABL90 FLEXOct 7, 2024
Manufacturer: RADIOMETER MEDICAL APS
Class: Kelas : 2
Risk Class: Kelas Resiko : B
BIOPANDA NT-proBNP Rapid TestSep 24, 2024
Manufacturer: BIOPANDA REAGENTS LTD
Class: Kelas : 2
Risk Class: Kelas Resiko : C
P Flex Ureteral Stent & SetSep 23, 2024
Manufacturer: BLUE NEEM MEDICAL DEVICES PRIVATE LIMITED
Class: Kelas : 2
Risk Class: Kelas Resiko : C
Bluthane Ureteral Stent & SetSep 19, 2024
Manufacturer: BLUE NEEM MEDICAL DEVICES PRIVATE LIMITED
Class: Kelas : 2
Risk Class: Kelas Resiko : C
TCM5 Basic MonitorSep 17, 2024
Manufacturer: PLEXUS SERVICES RO S.R.L.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
PVmed Contouring SoftwareSep 17, 2024
Manufacturer: GUANGZHOU PERCEPTION VISION MEDICAL TECHNOLOGY CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
DENSSIFLO PTBD CatheterSep 12, 2024
Manufacturer: BLUE NEEM MEDICAL DEVICES PRIVATE LIMITED
Class: Kelas : 2
Risk Class: Kelas Resiko : C
BLUE TAKE GuidewireSep 10, 2024
Manufacturer: BLUE NEEM MEDICAL DEVICES PRIVATE LIMITED
Class: Kelas : 2
Risk Class: Kelas Resiko : C
BLUE NEEM Percutaneous Nephrostomy Drainage Set - PigtailSep 6, 2024
Manufacturer: BLUE NEEM MEDICAL DEVICES PRIVATE LIMITED
Class: Kelas : 2
Risk Class: Kelas Resiko : C
PLINEST FAST Polynucleotides Intradermal GelSep 4, 2024
Manufacturer: MASTELLI S.R.L
Class: Kelas : 3
Risk Class: Kelas Resiko : D
PLINEST Polynucleotides Intradermal GelAug 27, 2024
Manufacturer: MASTELLI S.R.L
Class: Kelas : 3
Risk Class: Kelas Resiko : D
DENSSICATH Multi-Purpose Drainage Catheter & SetAug 26, 2024
Manufacturer: BLUE NEEM MEDICAL DEVICES PRIVATE LIMITED
Class: Kelas : 2
Risk Class: Kelas Resiko : C
EDWARDS Bioprostheses Heart Valve Accessories Use With Model 11400MAug 13, 2024
Manufacturer: EDWARDS LIFESCIENCES LLC.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
SCHÖLLY NIR FI Light SourceAug 13, 2024
Manufacturer: SCHÖLLY FIBEROPTIC GMBH.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
PSLOVE BackHeatAug 13, 2024
Manufacturer: TAIZHOU BRANCH OF SHANGHAI YINGDU INDUSTRY CO., LTD.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
BLUE NEEM Ureteral CatheterAug 7, 2024
Manufacturer: BLUE NEEM MEDICAL DEVICES PRIVATE LIMITED
Class: Kelas : 2
Risk Class: Kelas Resiko : C
PROVIDED Universal Bur HolderAug 7, 2024
Manufacturer: VERSAH LLC.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
SCHÖLLY CamerasAug 7, 2024
Manufacturer: SCHOLLY FIBEROPTIC GMBH.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
VERSAH Tapered Pilot DrillAug 4, 2024
Manufacturer: VERSAH LLC.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
PROVIDED Densah BursAug 4, 2024
Manufacturer: VERSAH LLC.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
PROVIDED Parallel PinsAug 4, 2024
Manufacturer: VERSAH LLC.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
PRAVEZA Ureteral Access SheathAug 1, 2024
Manufacturer: BLUE NEEM MEDICAL DEVICES PRIVATE LIMITED
Class: Kelas : 2
Risk Class: Kelas Resiko : C
SCHÖLLY Light SourceJul 31, 2024
Manufacturer: SCHOLLY FIBEROPTIC GMBH.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
PICOCAREMAJESTYJul 29, 2024
Manufacturer: WON TECH CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
OLIGIOJul 29, 2024
Manufacturer: WON TECH CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
Oligio KissJul 29, 2024
Manufacturer: WON TECH CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
INNO-LiPA HPV Genotyping Extra II Amp <20T, CE>Jul 9, 2024
Manufacturer: FUJIREBIO EUROPE N.V.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
INNO-LiPA HPV Genotyping Extra II <20T,CE>Jul 9, 2024
Manufacturer: FUJIREBIO EUROPE N.V.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
WETLING WMCS - Wireless Micro Current StimulationJun 28, 2024
Manufacturer: WETLING EU APS.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
BLOOD MenstruHeatJun 28, 2024
Manufacturer: TAIZHOU BRANCH OF SHANGHAI YINGDU INDUSTRY CO., LTD.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
N QUADRA Stone BasketJun 27, 2024
Manufacturer: BLUE NEEM MEDICAL DEVICES PRIVATE LIMITED
Class: Kelas : 2
Risk Class: Kelas Resiko : B
XPECTVISION Digital Intraoral X-ray SensorJun 24, 2024
Manufacturer: SHENZHEN XPECTVISION TECHNOLOGY CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
Ureteral DilatorsJun 22, 2024
Manufacturer: BLUE NEEM MEDICAL DEVICES PRIVATE LIMITED
Class: Kelas : 2
Risk Class: Kelas Resiko : B
OPTICORE Biopsy Gun - Fully AutomaticJun 22, 2024
Manufacturer: BLUE NEEM MEDICAL DEVICES PRIVATE LIMITED
Class: Kelas : 2
Risk Class: Kelas Resiko : B
CYTOCORE Biopsy Gun - Semi AutomaticJun 22, 2024
Manufacturer: BLUE NEEM MEDICAL DEVICES PRIVATE LIMITED
Class: Kelas : 2
Risk Class: Kelas Resiko : B
EYEOP-PACKMay 14, 2024
Manufacturer: EYE TECH CARE
Class: Kelas : 2
Risk Class: Kelas Resiko : C
BOTTOM BOTMay 7, 2024
Manufacturer: RED&BLUE CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
PERMEADERM Biosynthetic Wound MatrixMay 6, 2024
Manufacturer: TRELLEBORG SEALING SOLUTIONS US, INC.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
VUNO Med - Chest X-rayApr 29, 2024
Manufacturer: VUNO INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
VUNO Med - Fundus AIApr 29, 2024
Manufacturer: VUNO INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
VUNO Med - LungCT AIApr 29, 2024
Manufacturer: VUNO INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
VUNO Med - DeepBrainApr 29, 2024
Manufacturer: VUNO INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
CELLO AudiometerApr 25, 2024
Manufacturer: INVENTIS S.R.L.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
INNO-LIA HIV I/II ScoreApr 22, 2024
Manufacturer: FUJIREBIO EUROPE N.V.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
INVENTIS Middle Ear Analyzer ViolaApr 5, 2024
Manufacturer: INVENTIS S.R.L.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
REMISSION 1°CApr 4, 2024
Manufacturer: ADIPOLABS CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
INVENTIS Middle Ear Analyzer Flute BasicApr 2, 2024
Manufacturer: INVENTIS S.R.L.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
INVENTIS Middle Ear Analyzer Clarinet PlusApr 2, 2024
Manufacturer: INVENTIS S.R.L
Class: Kelas : 2
Risk Class: Kelas Resiko : B
INVENTIS Piccolo SpeechApr 2, 2024
Manufacturer: INVENTIS S.R.L
Class: Kelas : 2
Risk Class: Kelas Resiko : B
SPINECOR Dynamic Corrective BraceMar 29, 2024
Manufacturer: THE SPINECORPORATION LIMITED
Class: Kelas : 1
Risk Class: Kelas Resiko : A
TITAN Optimax Activ Titanium-NO Active Coronary StentMar 29, 2024
Manufacturer: HEXACATH
Class: Kelas : 3
Risk Class: Kelas Resiko : D
TIMPANI Handheld Tympanometer / Screening AudiometerMar 28, 2024
Manufacturer: INVENTIS S.R.L.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
TITAN OPTIMAX Titanium-NO Active Coronary StentMar 24, 2024
Manufacturer: HEXACATH
Class: Kelas : 3
Risk Class: Kelas Resiko : D
INNOTEST β-AMYLOID(1-40)Feb 13, 2024
Manufacturer: FUJIREBIO EUROPE N.V.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
INNOTEST PHOSPHO-TAU (181P)Feb 13, 2024
Manufacturer: FUJIREBIO EUROPE N.V.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
INNO-LIA HCV ScoreFeb 7, 2024
Manufacturer: FUJIREBIO EUROPE N.V.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
MEDIT Intraoral Scanner i600Jan 17, 2024
Manufacturer: MEDIT CORP.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
MEDIT Intraoral Scanner i700Jan 16, 2024
Manufacturer: MEDIT CORP.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
DOUBLE MEDICAL Hip Joint ProsthesisJan 14, 2024
Manufacturer: DOUBLE MEDICAL TECHNOLOGY INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
INNOTEST β-AMYLOID(1-42)Jan 11, 2024
Manufacturer: FUJIREBIO EUROPE N.V.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
INNOTEST hTau AgJan 11, 2024
Manufacturer: FUJIREBIO EUROPE N.V.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
TendigoJan 9, 2024
Manufacturer: FUJIREBIO EUROPE N.V.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
CARPENTIER-EDWARDS PERIMOUNT Magna Ease Pericardial BioprosthesisDec 28, 2023
Manufacturer: EDWARDS LIFESCIENCES COSTA RICA S.R.L
Class: Kelas : 3
Risk Class: Kelas Resiko : D
BLOOD KneeHeatDec 17, 2023
Manufacturer: TAIZHOU BRANCH OF SHANGHAI YINGDU INDUSTRY CO., LTD.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
On-X Aortic Prosthetic Heart Valve - Anatomic Sewing Ring, Extended HolderDec 10, 2023
Manufacturer: ON-X LIFE TECHNOLOGIES, INC.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
LUCA V-Defense Nasal SprayDec 5, 2023
Manufacturer: LUCA AICELL, INC
Class: Kelas : 2
Risk Class: Kelas Resiko : B
On-X® Prosthetic Heart Valve InstrumentsDec 4, 2023
Manufacturer: ON-X LIFE TECHNOLOGIES, INC.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
ON-X® Conform-X® Aortic Prosthetic Heart Valve – Extended HolderDec 4, 2023
Manufacturer: ON-X LIFE TECHNOLOGIES, INC.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
INSPIRIS RESILIA Aortic ValveNov 18, 2023
Manufacturer: EDWARDS LIFESCIENCES (SINGAPORE) PTE. LTD
Class: Kelas : 3
Risk Class: Kelas Resiko : D
On-X Aortic Prosthetic Heart Valve – Extended HolderNov 18, 2023
Manufacturer: ON-X LIFE TECHNOLOGIES, INC.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
INSPIRIS RESILIA Aortic ValveNov 18, 2023
Manufacturer: EDWARDS LIFESCIENCES LLC
Class: Kelas : 3
Risk Class: Kelas Resiko : D
CARPENTIER-EDWARDS PERIMOUNT Magna Ease Pericardial BioprosthesisNov 18, 2023
Manufacturer: EDWARDS LIFESCIENCES (SINGAPORE) PTE. LTD
Class: Kelas : 3
Risk Class: Kelas Resiko : D
Carpentier-Edwards Physio II Annuloplasty RingNov 17, 2023
Manufacturer: EDWARDS LIFESCIENCES LLC
Class: Kelas : 2
Risk Class: Kelas Resiko : C
Carpentier-Edwards Physio Annuloplasty RingNov 17, 2023
Manufacturer: EDWARDS LIFESCIENCES LLC
Class: Kelas : 2
Risk Class: Kelas Resiko : C
ON-X Mitral Prosthetic Heart ValveNov 14, 2023
Manufacturer: ON-X LIFE TECHNOLOGIES, INC.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
LORIENT No.6 Cross-linked Hyaluronic acid with LidocaineNov 14, 2023
Manufacturer: JOONGHUN PHARMACEUTICAL CO., LTD.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
On-X® Conform-X® Mitral Prosthetic Heart ValveNov 14, 2023
Manufacturer: ON-X LIFE TECHNOLOGIES, INC.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
LORIENT No.4 Cross-linked Hyaluronic acid with LidocaineNov 14, 2023
Manufacturer: JOONGHUN PHARMACEUTICAL CO., LTD.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
LORIENT No.2 Cross-linked Hyaluronic acid with LidocaineNov 14, 2023
Manufacturer: JOONGHUN PHARMACEUTICAL CO., LTD.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
EDWARDS LIFESCIENCES Annuloplasty Rings Accessories Sizers Use with models 4500, 4600, 4900, 6200Nov 13, 2023
Manufacturer: EDWARDS LIFESCIENCES LLC
Class: Kelas : 1
Risk Class: Kelas Resiko : A
BLOOD Panty Pads 50cm (L-XL)Nov 13, 2023
Manufacturer: QUANZHOU HUIFENG SANITARY ARTICLES CO., LTD.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
EDWARDS LIFESCIENCES Disposable HandleNov 13, 2023
Manufacturer: EDWARDS LIFESCIENCES LLC
Class: Kelas : 1
Risk Class: Kelas Resiko : A
BLOOD Sanitary Pads 41 cmNov 13, 2023
Manufacturer: QUANZHOU HUIFENG SANITARY ARTICLES CO., LTD.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
PANTHER HEALTHCARE Circular StaplerNov 8, 2023
Manufacturer: B.J.ZH.F. PANTHER MEDICAL EQUIPMENT CO., LTD
Class: Kelas : 2
Risk Class: Kelas Resiko : C
CARPENTIER-EDWARDS Bioprostheses Accessories Use With model 3000, 3300TFX, 8300AB, 8300KITB, 11500ANov 6, 2023
Manufacturer: EDWARDS LIFESCIENCES LLC
Class: Kelas : 1
Risk Class: Kelas Resiko : A
PANTHER HEALTHCARE Linear Stapler and Reloading UnitsNov 6, 2023
Manufacturer: B.J.ZH.F. PANTHER MEDICAL EQUIPMENT CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
EDWARDS LIFESCIENCES Annuloplasty Rings Accessories Use with models 4100, 4400, 4450, 4600, 5200Nov 6, 2023
Manufacturer: EDWARDS LIFESCIENCES LLC
Class: Kelas : 1
Risk Class: Kelas Resiko : A
Cosgrove-Edwards Annuloplasty SystemNov 3, 2023
Manufacturer: EDWARDS LIFESCIENCES LLC
Class: Kelas : 2
Risk Class: Kelas Resiko : C
PANTHER HEALTHCARE Cutter Stapler and Reloading Unit for Cutter StaplerNov 3, 2023
Manufacturer: B.J.ZH.F. PANTHER MEDICAL EQUIPMENT CO., LTD
Class: Kelas : 2
Risk Class: Kelas Resiko : C
TruWave Disposable Pressure Transducer (DPT) and Pressure Monitoring KitOct 25, 2023
Manufacturer: EDWARDS LIFESCIENCES AG
Class: Kelas : 2
Risk Class: Kelas Resiko : C
Edwards VAMP Closed Blood Sampling SystemOct 25, 2023
Manufacturer: EDWARDS LIFESCIENCES AG
Class: Kelas : 2
Risk Class: Kelas Resiko : C
AFFACARE Ultrasonic Surgical SystemSep 21, 2023
Manufacturer: AFFACARE MEDICAL (BEIJING) CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
ACUMEN IQ Finger CuffSep 12, 2023
Manufacturer: EDWARDS LIFESCIENCES AG
Class: Kelas : 2
Risk Class: Kelas Resiko : B
I-FIX Abutment or Prosthesis of Dental ImplantsSep 7, 2023
Manufacturer: KAMAL ENCON INDUSTRIES LIMITED
Class: Kelas : 2
Risk Class: Kelas Resiko : C
WISER 3 Diode LaserAug 28, 2023
Manufacturer: LAMBDA SPA
Class: Kelas : 2
Risk Class: Kelas Resiko : C
WISER 2 Diode LaserAug 28, 2023
Manufacturer: LAMBDA SPA
Class: Kelas : 2
Risk Class: Kelas Resiko : C
DPLUS Diode Modul for Erbium LaserAug 24, 2023
Manufacturer: LAMBDA SPA.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
SIMPLER 2 Diode LaserAug 22, 2023
Manufacturer: LAMBDA SPA
Class: Kelas : 2
Risk Class: Kelas Resiko : C
PLUSER AND PLUSER KOMBI Erbium LaserAug 22, 2023
Manufacturer: LAMBDA SPA
Class: Kelas : 2
Risk Class: Kelas Resiko : C
SkinPen + SkinFuse Treatment KitAug 17, 2023
Manufacturer: CROWN AESTHETICS
Class: Kelas : 2
Risk Class: Kelas Resiko : B
SkinFuse Lift HGAug 7, 2023
Manufacturer: BIOMED LABORATORIES, LLC
Class: Kelas : 2
Risk Class: Kelas Resiko : B
SkinPen Precision Microneedling SystemAug 7, 2023
Manufacturer: COGMEDIX
Class: Kelas : 2
Risk Class: Kelas Resiko : B
EVOLIS SystemAug 2, 2023
Manufacturer: STRATEC SE
Class: Kelas : 2
Risk Class: Kelas Resiko : B
EVOLIS Twin PlusJul 26, 2023
Manufacturer: STRATEC BIOMEDICAL SWITZERLAND AG
Class: Kelas : 2
Risk Class: Kelas Resiko : B
Neuropen MonofilamentsJul 19, 2023
Manufacturer: OWEN MUMFORD SDN BHD
Class: Kelas : 1
Risk Class: Kelas Resiko : A
Neurotips™Jul 19, 2023
Manufacturer: OWEN MUMFORD SDN BHD
Class: Kelas : 1
Risk Class: Kelas Resiko : A
NeuropenJul 19, 2023
Manufacturer: OWEN MUMFORD SDN BHD
Class: Kelas : 1
Risk Class: Kelas Resiko : A
UNISTIK ShieldLockJul 7, 2023
Manufacturer: YANGZHOU MEDLINE INDUSTRY CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
Geenius HCV Supplemental AssayJun 19, 2023
Manufacturer: BIO-RAD. (STEENVOORDE)
Class: Kelas : 3
Risk Class: Kelas Resiko : D
MONOLISA HBs Ag ULTRAJun 19, 2023
Manufacturer: BIO-RAD
Class: Kelas : 3
Risk Class: Kelas Resiko : D
EZITELL hCG Pregnancy Rapid Test Cassette (Urine)Jun 13, 2023
Manufacturer: HANGZHOU ALLTEST BIOTECH CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
PROSTEOMAX Calcium Phosphate Bone CementJun 11, 2023
Manufacturer: GRANULAB (M) SDN., BHD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
GRANUMAS Synthetic Bone GraftJun 11, 2023
Manufacturer: GRANULAB (M) SDN BHD
Class: Kelas : 2
Risk Class: Kelas Resiko : C
CRAB Vaginal Hyal GelMay 31, 2023
Manufacturer: CRAB SINERGY SRL
Class: Kelas : 2
Risk Class: Kelas Resiko : B
UNIFINE PentipsApr 19, 2023
Manufacturer: PIKDARE S.R.L,
Class: Kelas : 2
Risk Class: Kelas Resiko : B
UNISTIK 3 ExtraApr 18, 2023
Manufacturer: OWEN MUMFORD SDN BHD
Class: Kelas : 1
Risk Class: Kelas Resiko : A
ENDOFORM™ Natural Restorative BioscaffoldApr 17, 2023
Manufacturer: AROA BIOSURGERY LTD.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
DIAMED IH-QC7 Modular SystemApr 7, 2023
Manufacturer: DIAMED GMBH
Class: Kelas : 2
Risk Class: Kelas Resiko : B
MiRXES CoVClear Covid-19 RT-PCR TestMar 24, 2023
Manufacturer: MIRXES PTE LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
DIAMED IH-QC5 Modular SystemMar 15, 2023
Manufacturer: DIAMED GMBH.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
DIAMED IH-QC4 Modular SystemMar 15, 2023
Manufacturer: DIAMED GMBH
Class: Kelas : 2
Risk Class: Kelas Resiko : B
DIAMED IH-QC6 Modular SystemMar 15, 2023
Manufacturer: DIAMED GMBH
Class: Kelas : 2
Risk Class: Kelas Resiko : B
DIAMED IH-QC8 Modular SystemMar 15, 2023
Manufacturer: DIAMED GMBH
Class: Kelas : 2
Risk Class: Kelas Resiko : B
DIAMED IH-QC3 Modular SystemMar 15, 2023
Manufacturer: DIAMED GMBH
Class: Kelas : 2
Risk Class: Kelas Resiko : B
DIAMED IH-QC2 Modular SystemMar 10, 2023
Manufacturer: DIAMED GMBH
Class: Kelas : 2
Risk Class: Kelas Resiko : B
ID-Diluent 2Feb 27, 2023
Manufacturer: DIAMED GMBH
Class: Kelas : 2
Risk Class: Kelas Resiko : B
MONOLISA HCV Ag-Ab ULTRA V2Feb 22, 2023
Manufacturer: BIO-RAD
Class: Kelas : 3
Risk Class: Kelas Resiko : D
ID-Diluent 1Feb 9, 2023
Manufacturer: DIAMED GMBH
Class: Kelas : 2
Risk Class: Kelas Resiko : B
ID- Titration SolutionFeb 8, 2023
Manufacturer: DIAMED GMBH.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
DENTALMASTER Dental Surgery DrillFeb 7, 2023
Manufacturer: DENTAL MASTER (XIAMEN) MEDICAL TECHNOLOGY CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
DENTALMASTER Dental Surgery InstrumentFeb 7, 2023
Manufacturer: DENTAL MASTER (XIAMEN) MEDICAL TECHNOLOGY CO., LTD.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
DENTALMASTER SLA Dental Implant SystemFeb 2, 2023
Manufacturer: DENTAL MASTER (XIAMEN) MEDICAL TECHNOLOGY CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
BIO-RAD PW40 Microplate WasherFeb 2, 2023
Manufacturer: BIO-RAD LABORATORIES (SINGAPORE) PTE. LTD.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
DENTALMASTER SLA Dental Implant System (Abutment)Feb 2, 2023
Manufacturer: DENTAL MASTER (XIAMEN) MEDICAL TECHNOLOGY CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
INNO-LIA Syphilis ScoreFeb 2, 2023
Manufacturer: FUJIREBIO EUROPE N.V.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
GEENIUS™ Reader and AccessoriesJan 26, 2023
Manufacturer: BIO-RAD
Class: Kelas : 1
Risk Class: Kelas Resiko : A
ID-Antigen Profile IIIJan 25, 2023
Manufacturer: DIAMED GMBH
Class: Kelas : 2
Risk Class: Kelas Resiko : C
Geenius™ HIV 1/2 Confirmatory ControlsJan 25, 2023
Manufacturer: BIO-RAD
Class: Kelas : 2
Risk Class: Kelas Resiko : B
DiaClon ABD-Confirmation for PatientsJan 25, 2023
Manufacturer: DIAMED GMBH.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
SAXO ID-Reader IIJan 25, 2023
Manufacturer: BIO-RAD LABORATORIES (SINGAPORE) PTE. LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
DIAMED Coombs Anti-IgGJan 25, 2023
Manufacturer: DIAMED GMBH.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
ID-DiaClon Anti-DJan 25, 2023
Manufacturer: DIAMED GMBH.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
DIAMED IH-QC1 Modular SystemJan 25, 2023
Manufacturer: DIAMED GMBH.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
BIO-RAD PR 4100 Microplate ReaderJan 25, 2023
Manufacturer: TECAN AUSTRIA GMBH
Class: Kelas : 1
Risk Class: Kelas Resiko : A
Geenius™ HCV Supplemental ControlsJan 25, 2023
Manufacturer: BIO-RAD
Class: Kelas : 2
Risk Class: Kelas Resiko : B
DiaClon ABO/D + Reverse Grouping for DonorsJan 25, 2023
Manufacturer: DIAMED GMBH
Class: Kelas : 2
Risk Class: Kelas Resiko : C
DiaClon ABD-Confirmation for DonorsJan 25, 2023
Manufacturer: DIAMED GMBH.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
DiaClon Rh-Subgroups + KJan 25, 2023
Manufacturer: DIAMED GMBH.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
BIO-RAD IH-1000 and AccessoriesJan 25, 2023
Manufacturer: BIO-RAD
Class: Kelas : 2
Risk Class: Kelas Resiko : C
DC-Screening IIJan 25, 2023
Manufacturer: DIAMED GMBH.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
BIO-RAD IH-500 and AccessoriesJan 1, 2023
Manufacturer: BIO-RAD LABORATORIES (SINGAPORE) PTE. LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
DIAMED NaCl, Enzyme Test and Cold AgglutininsDec 30, 2022
Manufacturer: DIAMED GMBH
Class: Kelas : 2
Risk Class: Kelas Resiko : C
BIO-RAD Syphilis Total AbDec 29, 2022
Manufacturer: BIO-RAD
Class: Kelas : 2
Risk Class: Kelas Resiko : C
ID - Antigen Profile IDec 27, 2022
Manufacturer: DIAMED GMBH
Class: Kelas : 2
Risk Class: Kelas Resiko : C
SCHOLLY Light Guide and AdapterDec 23, 2022
Manufacturer: SCHOLLY FIBEROPTIC GMBH.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
ID-Incubator L and AccessoriesDec 19, 2022
Manufacturer: BIO-RAD LABORATORIES (SINGAPORE) PTE. LTD.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
ID-DiaCell I-IIDec 10, 2022
Manufacturer: DIAMED GMBH
Class: Kelas : 2
Risk Class: Kelas Resiko : C
DiaClon ABO/D + Reverse GroupingDec 9, 2022
Manufacturer: DIAMED GMBH
Class: Kelas : 2
Risk Class: Kelas Resiko : C
DIAMED ID-DiaCell PoolDec 8, 2022
Manufacturer: DIAMED GMBH
Class: Kelas : 2
Risk Class: Kelas Resiko : C
DIAMED Wash Solution A ConcentrateNov 30, 2022
Manufacturer: DIAMED GMBH
Class: Kelas : 1
Risk Class: Kelas Resiko : A
DIAMED ID-Centrifuge L and AccessoriesNov 30, 2022
Manufacturer: BIO-RAD LABORATORIES (SINGAPORE) PTE. LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
HUGEMED Flexible Video UreterorenoscopeNov 21, 2022
Manufacturer: SHENZHEN HUGEMED MEDICAL TECHNICAL DEVELOPMENT CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
HUGEMED Flexible Video UreterorenoscopeNov 21, 2022
Manufacturer: SHENZHEN HUGEMED MEDICAL TECHNICAL DEVELOPMENT CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
HUGEMED Flexible Video UreterorenoscopeNov 21, 2022
Manufacturer: SHENZHEN HUGEMED MEDICAL TECHNICAL DEVELOPMENT CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
PANTHER HEALTHCARE Linear Cutter Stapler and Reloading Unit for Linear Cutter StaplerNov 10, 2022
Manufacturer: B.J.ZH.F. PANTHER MEDICAL EQUIPMENT CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
PANTHER HEALTHCARE Endo Linear Cutter Stapler and Reloading Unit for Endo Linear Cutter StaplerNov 6, 2022
Manufacturer: B.J.ZH.F. PANTHER MEDICAL EQUIPMENT CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
QXDx BCR-ABL %IS KitOct 29, 2022
Manufacturer: BIO-RAD LABORATORIES, INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
SCHÖLLY LaparoscopesOct 8, 2022
Manufacturer: SCHOLLY FIBEROPTIC GMBH.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
SCHÖLLY CystoscopesSep 29, 2022
Manufacturer: SCHOLLY FIBEROPTIC GMBH.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
CFX Opus 96 Dx with CFX Maestro Dx SE SoftwareSep 10, 2022
Manufacturer: BIO-RAD LABORATORIES (SINGAPORE) PTE LTD
Class: Kelas : 2
Risk Class: Kelas Resiko : B
EVEROSHINE Everolimus Eluting Coronary Stent SystemJul 22, 2022
Manufacturer: KAMAL ENCON INDUSTRIES LIMITED
Class: Kelas : 3
Risk Class: Kelas Resiko : D
STENOFLEX Sirolimus Eluting Coronary Stent SystemJul 22, 2022
Manufacturer: KAMAL ENCON INDUSTRIES LIMITED
Class: Kelas : 3
Risk Class: Kelas Resiko : D
INNOLCON Ultrasonic Surgical SystemJul 18, 2022
Manufacturer: INNOLCON MEDICAL TECHNOLOGY (SUZHOU) CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
BLOOD Panty Pads 50cm (M-L)Apr 21, 2022
Manufacturer: QUANZHOU HUIFENG SANITARY ARTICLES CO., LTD.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
BLOOD Panty Pads 50cm (S-M)Apr 21, 2022
Manufacturer: QUANZHOU HUIFENG SANITARY ARTICLES CO., LTD.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
BLOOD Sanitary Pads 15 cm (Liner)Apr 20, 2022
Manufacturer: QUANZHOU HUIFENG SANITARY ARTICLES CO., LTD.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
BLOOD Sanitary Pads 29 cmApr 20, 2022
Manufacturer: QUANZHOU HUIFENG SANITARY ARTICLES CO., LTD.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
BLOOD Sanitary Pads 25 cmApr 20, 2022
Manufacturer: QUANZHOU HUIFENG SANITARY ARTICLES CO., LTD.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
BLOOD Sanitary Pads 33 cmApr 20, 2022
Manufacturer: QUANZHOU HUIFENG SANITARY ARTICLES CO., LTD.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
SKYFLOW Thrombectomy DeviceFeb 10, 2022
Manufacturer: SKYNOR MEDICAL (SHANGHAI) CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
TIMEWAVERMar 3, 2021
Manufacturer: TIMEWAVER PRODUCTION GMBH
Class: Kelas : 2
Risk Class: Kelas Resiko : C
TIMEWAVER FrequencyMar 3, 2021
Manufacturer: TIMEWAVER PRODUCTION GMBH
Class: Kelas : 2
Risk Class: Kelas Resiko : C
FOCUS & FUSION Ultrasound Diagnostic SystemFeb 22, 2021
Manufacturer: FOCUS & FUSION HEALTHCARE (HANGZHOU) CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
FOCUS & FUSION Ultrasound Diagnostic SystemFeb 22, 2021
Manufacturer: FOCUS & FUSION HEALTHCARE (HANGZHOU) CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
HEALYFeb 18, 2021
Manufacturer: HEALY GMBH
Class: Kelas : 2
Risk Class: Kelas Resiko : C
ENDOFORM Antimicrobial Dermal TemplateApr 20, 2020
Manufacturer: AROA BIOSURGERY LTD.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
ENDOFORM Natural Dermal TemplateApr 20, 2020
Manufacturer: AROA BIOSURGERY LTD.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
BJ-KMC Shaver SystemApr 7, 2020
Manufacturer: SHANGHAI BJ-KMC MEDICAL TECHNOLOGY CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
LnK Spinal Instrument System - Surgical Drill HandpieceDec 6, 2019
Manufacturer: L&K BIOMED CO., LTD.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
LnK Spinal Instrument SystemDec 6, 2019
Manufacturer: L&K BIOMED CO., LTD.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
MEDIT Intraoral Scanner i500Nov 13, 2019
Manufacturer: MEDIT CORP.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
HANALYTICS BioMind Diagnostic Support SoftwareNov 5, 2019
Manufacturer: HANALYTICS PTE., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
PSLOVE MenstruHeatNov 1, 2019
Manufacturer: TAIZHOU BRANCH OF SHANGHAI YINGDU INDUSTRY CO., LTD.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
INVENTIS Portable Audiometer Piccolo Speech AeroSep 6, 2019
Manufacturer: INVENTIS S.R.L
Class: Kelas : 2
Risk Class: Kelas Resiko : B
INVENTIS Piccolo PlusSep 6, 2019
Manufacturer: INVENTIS S.R.L
Class: Kelas : 2
Risk Class: Kelas Resiko : B
INVENTIS Portable Audiometer Piccolo Basic AeroSep 6, 2019
Manufacturer: INVENTIS S.R.L
Class: Kelas : 2
Risk Class: Kelas Resiko : B
INVENTIS Middle Ear AnalyzerSep 6, 2019
Manufacturer: INVENTIS S.R.L
Class: Kelas : 2
Risk Class: Kelas Resiko : B
INVENTIS Middle Ear Analyzer Clarinet BasicSep 2, 2019
Manufacturer: INVENTIS S.R.L.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
INVENTIS Middle Ear Analyzer AudiometerSep 2, 2019
Manufacturer: INVENTIS S.R.L
Class: Kelas : 2
Risk Class: Kelas Resiko : B
INVENTIS Portable AudiometerSep 2, 2019
Manufacturer: INVENTIS S.R.L
Class: Kelas : 2
Risk Class: Kelas Resiko : B
INVENTIS Flute HFSep 2, 2019
Manufacturer: INVENTIS S.R.L.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
INNO-LiPA Mycobacteria v2 Amp <20T, CE>Aug 16, 2019
Manufacturer: FUJIREBIO EUROPE N.V.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
INNO-LiPA Mycobacteria v2 <20T, CE>Aug 16, 2019
Manufacturer: FUJIREBIO EUROPE N.V.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
OPENLOC-L Spinal Fixation SystemFeb 27, 2019
Manufacturer: L&K BIOMED CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
OPENLOC-L Spinal Fixation SystemFeb 27, 2019
Manufacturer: L&K BIOMED CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
OPENLOC-L Spinal Fixation SystemFeb 26, 2019
Manufacturer: L&K BIOMED CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
OPENLOC-L Spinal Fixation SystemFeb 26, 2019
Manufacturer: L&K BIOMED CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
OPENLOC-L Spinal Fixation SystemFeb 26, 2019
Manufacturer: L&K BIOMED CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
OPENLOC-L Spinal Fixation SystemFeb 22, 2019
Manufacturer: L&K BIOMED CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
OPENLOC-L Spinal Fixation SystemFeb 22, 2019
Manufacturer: L&K BIOMED CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
OPENLOC-L Spinal Fixation SystemFeb 22, 2019
Manufacturer: L&K BIOMED CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
PATHLOC-LC Lateral Cage SystemFeb 18, 2019
Manufacturer: L&K BIOMED CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
OPENLOC-L Spinal Fixation SystemFeb 18, 2019
Manufacturer: L&K BIOMED CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
OPENLOC-L Spinal Fixation SystemFeb 18, 2019
Manufacturer: L&K BIOMED CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
OPENLOC-L Spinal Fixation SystemFeb 18, 2019
Manufacturer: L&K BIOMED CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
PATHLOC-L MIS Spinal SystemFeb 18, 2019
Manufacturer: L&K BIOMED CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
OPENLOC-L Spinal Fixation SystemFeb 18, 2019
Manufacturer: L&K BIOMED CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
PATHLOC-LC Lateral Cage SystemFeb 18, 2019
Manufacturer: L&K BIOMED CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
OPEN LOC-L Spinal Fixation SystemFeb 18, 2019
Manufacturer: L&K BIOMED CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
OPENLOC-L Spinal Fixation SystemFeb 18, 2019
Manufacturer: L&K BIOMED CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
PATHLOC-LC Lateral Cage SystemFeb 18, 2019
Manufacturer: L&K BIOMED CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
OPENLOC-L Spinal Fixation SystemFeb 18, 2019
Manufacturer: L&K BIOMED CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
OPENLOC-L Spinal Fixation SystemFeb 18, 2019
Manufacturer: L&K BIOMED CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
CASTLELOC-S Posterior Cervical Fixation SystemFeb 15, 2019
Manufacturer: L&K BIOMED CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
PATHLOC-L MIS Spinal SystemFeb 15, 2019
Manufacturer: L&K BIOMED CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
LnK Lumbar Interbody Fusion Cage SystemFeb 15, 2019
Manufacturer: L&K BIOMED CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
CASTLELOC-P Anterior Cervical Plate SystemFeb 15, 2019
Manufacturer: L&K BIOMED CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
OPENLOC-L Spinal Fixation SystemFeb 15, 2019
Manufacturer: L&K BIOMED CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
PATHLOC-L MIS Spinal System, MIS ScrewFeb 8, 2019
Manufacturer: L&K BIOMED CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
CASTLELOC-C Cervical Interbody Fusion Cage SystemFeb 8, 2019
Manufacturer: L&K BIOMED CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
CASTLELOC-S Posterior Cervical Fixation SystemFeb 8, 2019
Manufacturer: L&K BIOMED CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
About this profile
Data sourced from BPOM (Badan Pengawas Obat dan Makanan), Indonesia.
Last updated: July 2026