Pure Global AI
Medical device manufacturer

MacroLux Medical Technology

Public medical device registrations for MacroLux Medical Technology across 11 markets.

Urology
Airway management
Gynecology
ENT
Official-source data MacroLux Medical Technology Co., Ltd. 11 marketsShenzhen, China

Regulatory footprint

55 public registry records across 11 markets.

Public company intelligence

Regulatory portfolio at a glance

Public registration activity across the markets currently covered by our databases.

55

Registry records

54 unique registration numbers

11

Markets

Brazil · Canada · Colombia · Ecuador · Mexico · United States · Indonesia · Malaysia · Singapore · Saudi Arabia · United Kingdom

49

Product records

Product names across markets

29

Active records

15 record statuses not published

Markets

Market footprint

Brazil flag

Brazil

ANVISA · regulatory records

6 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

Browse Brazil records
Canada flag

Canada

Health Canada · regulatory records

9 records
Published dates
2025 – 2026
Risk classes
Class II
Registered products
8
Active registrations
9

Local regulatory party

Not published

Browse Canada records
Colombia flag

Colombia

INVIMA · regulatory records

1 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

Browse Colombia records
Ecuador flag

Ecuador

ARCSA · regulatory records

5 records
Published dates
2024 – 2025
Risk classes
Not published
Registered products
5
Active registrations
5

Local regulatory party

BIOELECTRONICA BLANCO BLANCOSA S.A.

Browse Ecuador records
Mexico flag

Mexico

COFEPRIS · regulatory records

2 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.

Browse Mexico records
United States flag

United States

FDA · regulatory records

7 records
Published dates
2024 – 2026
Risk classes
Class II
Registered products
7
Active registrations
0

Local regulatory party

Not published

Browse United States records
Indonesia flag

Indonesia

Ministry of Health · regulatory records

3 records
Published dates
2024 – 2024
Risk classes
Class B
Registered products
3
Active registrations
0

Local regulatory party

INDOMEDIK NIAGA PERKASA

Browse Indonesia records
Malaysia flag

Malaysia

MDA · regulatory records

4 records
Published dates
2024 – 2024
Risk classes
Class B
Registered products
4
Active registrations
4

Local regulatory party

EVOMEDIC SDN BHD

Browse Malaysia records
Singapore flag

Singapore

HSA · regulatory records

4 records
Published dates
2024 – 2025
Risk classes
Class B
Registered products
4
Active registrations
0

Local regulatory party

QST TECHNOLOGIES PTE. LTD. · Radiance Medical Systems

Browse Singapore records
Saudi Arabia flag

Saudi Arabia

SFDA · regulatory records

4 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

Browse Saudi Arabia records
United Kingdom flag

United Kingdom

MHRA · regulatory records

10 records
Published dates
2024 – 2024
Risk classes
Not published
Registered products
5
Active registrations
0

Local regulatory party

Wellkang Ltd

Browse United Kingdom records

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Company records

Public registrations

1–25 of 55

ProductMarketClassStatusDates
BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)

K260516

United StatesClass II
Cleared

IssuedJul 20, 2026

CORALWELL.

0655E2026 SSA

MexicoClass II
Not published

IssuedApr 21, 2026

LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)

K260420

United StatesClass II
Cleared

IssuedApr 8, 2026

CORALWELL SINGLE-USE URETERAL ACCESS SHEATH

114999

CanadaClass II
Active

IssuedFeb 27, 2026

Broncoscópio Flexível Digital de Uso Único LoopView

82195309097

BrazilClass II
Active

IssuedDec 29, 2025

Histeroscópio Digital de Uso Único SeleneView

82195309084

BrazilClass II
Active

IssuedDec 8, 2025

Vídeo Processador ViewHub

82195309089

BrazilClass II
Active

IssuedDec 8, 2025

Cistoscópio Flexível Digital de Uso Único BubbleView

82195309085

BrazilClass II
Active

IssuedDec 8, 2025

Ureteroscópio flexível digital de uso único CoralView

82195309082

BrazilClass II
Active

IssuedNov 24, 2025

CoralWell – Bainha de Acesso Ureteral de Uso Único

82195309060

BrazilClass II
Active

IssuedNov 10, 2025

SINGLE-USE DIGITAL FLEXIBLE BRONCHOSCOPE

114103

CanadaClass II
Active

IssuedOct 7, 2025

MACROLUX CORALVIEW® SINGLE-USE DIGITAL FLEXIBLE URETEROSCOPE

1736E2025 SSA

MexicoClass II
Not published

IssuedSep 17, 2025

BUBBLEVIEW SINGLE-USE DIGITAL FLEXIBLE CYSTOSCOPE

113871

CanadaClass II
Active

IssuedAug 26, 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 StatesClass II
Cleared

IssuedJun 2, 2025

Single-Use Digital Flexible Cystoscope

18554-DME-0425

EcuadorNot published
Active

IssuedApr 28, 2025

Valid until Apr 28, 2030

Single-Use Digital Flexible Bronchoscope

18560-DME-0425

EcuadorNot published
Active

IssuedApr 28, 2025

Valid until Apr 28, 2030

Single-Use Digital Hysteroscope

18554-DME-0425

EcuadorNot published
Active

IssuedApr 28, 2025

Valid until Apr 28, 2030

SINGLE-USE DIGITAL HYSTEROSCOPE

112821

CanadaClass II
Active

IssuedMar 6, 2025

BUBBLEVIEW SINGLE-USE DIGITAL FLEXIBLE CYSTOSCOPE

112683

CanadaClass II
Active

IssuedFeb 10, 2025

SELENEVIEW SINGLE-USE DIGITAL HYSTEROSCOPE

112684

CanadaClass II
Active

IssuedFeb 10, 2025

VIDEO PROCESSOR

112674

CanadaClass II
Active

IssuedFeb 7, 2025

LOOPVIEW SINGLE-USE DIGITAL FLEXIBLE BRONCHOSCOPE

112675

CanadaClass II
Active

IssuedFeb 7, 2025

CORALVIEW SINGLE-USE DIGITAL FLEXIBLE URETEROSCOPE

112677

CanadaClass II
Active

IssuedFeb 7, 2025

MacroLux Medical Technology SeleneView® Single-Use Digital Hysteroscope

DE0510260

SingaporeClass B
Expired

IssuedJan 17, 2025

Valid until Jan 16, 2026

Flexible video ureteroscope, single-use

198318

United KingdomNot published
Not published

IssuedNov 26, 2024

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