MacroLux Medical Technology
Public medical device registrations for MacroLux Medical Technology across 9 markets.
Regulatory footprint
47 public registry records across 9 markets.
Public company intelligence
Regulatory portfolio at a glance
Public registration activity across the markets currently covered by our databases.
47
Registry records
46 unique registration numbers
9
Markets
Brazil · Colombia · Ecuador · Mexico · United States · Malaysia · Singapore · Saudi Arabia · United Kingdom
42
Product records
Product names across markets
20
Active records
8 record statuses not published
Markets
Market footprint
Brazil
ANVISA · regulatory records
- Published dates
- 2025 – 2025
- Risk classes
- Class II
- Registered products
- 6
- Active registrations
- 6
Local regulatory party
PURE LATAM BRAZIL COMERCIO DE PRODUTOS HOSPITALARES LTDA
Colombia
INVIMA · regulatory records
- Published dates
- Valid until Dec 4, 2035
- Risk classes
- Class IIa
- Registered products
- 1
- Active registrations
- 1
Local regulatory party
PURE LATAM COLOMBIA S.A.S
Ecuador
ARCSA · regulatory records
- Published dates
- 2024 – 2025
- Risk classes
- Not published
- Registered products
- 5
- Active registrations
- 5
Local regulatory party
BIOELECTRONICA BLANCO BLANCOSA S.A.
Mexico
COFEPRIS · regulatory records
- Published dates
- 2025 – 2026
- Risk classes
- Class II
- Registered products
- 2
- Active registrations
- 0
Local regulatory party
CONTROL SCIENTIFIC, S.A. DE C.V. · PURE LATAM MEXICO, S. DE R.L. DE C.V.
United States
FDA · regulatory records
- Published dates
- 2024 – 2026
- Risk classes
- Not published
- Registered products
- 7
- Active registrations
- 0
Local regulatory party
MacroLux Medical Technology Co., Ltd.
Malaysia
MDA · regulatory records
- Published dates
- 2024 – 2024
- Risk classes
- Not published
- Registered products
- 4
- Active registrations
- 4
Local regulatory party
EVOMEDIC SDN BHD
Singapore
HSA · regulatory records
- Published dates
- 2024 – 2026
- Risk classes
- Class B
- Registered products
- 6
- Active registrations
- 0
Local regulatory party
QST TECHNOLOGIES PTE. LTD. · RADIANCE MEDICAL SYSTEMS
Saudi Arabia
SFDA · regulatory records
- Published dates
- Valid until Sep 12, 2027
- Risk classes
- Class II, Class I
- Registered products
- 4
- Active registrations
- 4
Local regulatory party
Not published
United Kingdom
MHRA · regulatory records
- Published dates
- 2023 – 2026
- Risk classes
- Not published
- Registered products
- 7
- Active registrations
- 0
Local regulatory party
Not published
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Open AI analysisCompany records
Public registrations
1–25 of 47
| Product | Market | Class | Status | Dates |
|---|---|---|---|---|
| BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR) K260516 | United States | Not published | Substantially Equivalent | IssuedJul 20, 2026 |
| Flexible video otorhinolaryngoscope, single-use | United Kingdom | Not published | Registered | IssuedJun 16, 2026 |
| Macrolux BubbleView Single-Use Digital Flexible Cystoscope MDPR260508D0001 | Singapore | Class B | Not published | IssuedMay 8, 2026 |
| CORALWELL. 0655E2026 SSA | Mexico | Class II | Not published | IssuedApr 21, 2026 |
| LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG) K260420 | United States | Not published | Substantially Equivalent | IssuedApr 8, 2026 |
| Flexible video bronchoscope, single-use | United Kingdom | Not published | Registered | IssuedDec 30, 2025 |
| Ureteral introduction sheath | United Kingdom | Not published | Registered | IssuedDec 30, 2025 |
| Flexible video cystoscope, single-use | United Kingdom | Not published | Registered | IssuedDec 30, 2025 |
| Broncoscópio Flexível Digital de Uso Único LoopView 82195309097 | Brazil | Class II | Active | IssuedDec 29, 2025 |
| Histeroscópio Digital de Uso Único SeleneView 82195309084 | Brazil | Class II | Active | IssuedDec 8, 2025 |
| Vídeo Processador ViewHub 82195309089 | Brazil | Class II | Active | IssuedDec 8, 2025 |
| Cistoscópio Flexível Digital de Uso Único BubbleView 82195309085 | Brazil | Class II | Active | IssuedDec 8, 2025 |
| Ureteroscópio flexível digital de uso único CoralView 82195309082 | Brazil | Class II | Active | IssuedNov 24, 2025 |
| CoralWell – Bainha de Acesso Ureteral de Uso Único 82195309060 | Brazil | Class II | Active | IssuedNov 10, 2025 |
| CoralWell Single-use Ureteral Access Sheath MDPR251031W0003 | Singapore | Class B | Not published | IssuedOct 31, 2025 |
| MACROLUX CORALVIEW® SINGLE-USE DIGITAL FLEXIBLE URETEROSCOPE 1736E2025 SSA | Mexico | Class II | Not published | IssuedSep 17, 2025 |
| CoralWell™ Single-use Ureteral Access Sheath (NS-0835B, NS-0840B, NS-0845B, NS-0855B, NS-0935B, NS-0940B, NS-0945B, NS-0955B, NS-1035B, NS-1040B, NS-1045B, NS-1055B, NS-1135B, NS-1140B, NS-1145B, NS-1155B, NS-1235B, NS-1240B, NS-1245B, NS-1255B, NS-1335B, NS-1340B, NS-1345B, NS-1355B, NS-1435B, NS-1440B, NS-1445B, NS-1455B) K250452 | United States | Not published | Substantially Equivalent | IssuedJun 2, 2025 |
| Single-Use Digital Flexible Cystoscope 18554-DME-0425 | Ecuador | Not published | Active | IssuedApr 28, 2025 Valid until Apr 28, 2030 |
| Single-Use Digital Flexible Bronchoscope 18560-DME-0425 | Ecuador | Not published | Active | IssuedApr 28, 2025 Valid until Apr 28, 2030 |
| Single-Use Digital Hysteroscope 18554-DME-0425 | Ecuador | Not published | Active | IssuedApr 28, 2025 Valid until Apr 28, 2030 |
| MacroLux Medical Technology SeleneView® Single-Use Digital Hysteroscope DE0510260 | Singapore | Class B | Not published | IssuedJan 17, 2025 |
| MacroLux Medical Technology LoopView® Single-Use Digital Flexible Bronchoscope DE0510062 | Singapore | Class B | Not published | IssuedNov 20, 2024 |
| Rigid video hysteroscope | United Kingdom | Not published | Registered | IssuedNov 1, 2024 |
| Rigid video hysteroscope | United Kingdom | Not published | Registered | IssuedNov 1, 2024 |
| Flexible video cystoscope, single-use | United Kingdom | Not published | Registered | IssuedNov 1, 2024 |
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