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Male Latex Condoms
EUDAMEDClass IIb (EU MDR)
Ref 53mmModel small size (49±2mm) , medium size (53mm±2mm), large size (55mm±2mm), extra-large size (58mm±2mm); Smooth, Studs, RibsRef 53mm±2mmRef 55mm±2mmModel small size (49±2mm) , medium size (53mm±2mm), large size (55mm±2mm), extra-large size (58mm±2mm); Smooth, Studs(Dotted), Ribs(Ribbed)
Identity
- Trade Name
- Male Latex Condoms EUDAMED
- Device Name
- Male Latex Condoms EUDAMED
- Model / Reference
- small size (49±2mm) , medium size (53mm±2mm), large size (55mm±2mm), extra-large size (58mm±2mm); Smooth, Studs, Ribs EUDAMED53mm EUDAMED53mm±2mm EUDAMEDsmall size (49±2mm) , medium size (53mm±2mm), large size (55mm±2mm), extra-large size (58mm±2mm); Smooth, Studs(Dotted), Ribs(Ribbed) EUDAMED55mm±2mm EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925634024250 EUDAMED06925634024267 EUDAMED06925634024380 EUDAMED06925634024410 EUDAMED
- Basic UDI-DI
- 69256340MLC3H EUDAMED
- Direct Marketing DI
- 06925634024250 EUDAMED06925634024267 EUDAMED06925634024380 EUDAMED06925634024410 EUDAMED
- EMDN Code
- U110101 CONDOMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Male Latex Condoms by Suzhou Colour-way New Material Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69256340MLC3H | Class IIb | Active |
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Manufacturer
- Manufacturer
- Suzhou Colour-way New Material Co., Ltd.
- EUDAMED SRN
- CN-MF-000027396
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (4)
- EUDAMED 982f74c6-da2e-44da-9614-e1975bba7c77 61 fields · synced Sep 30, 2026
- EUDAMED e3358945-bf5d-4df6-9c08-573eb6562a4d 61 fields · synced May 19, 2026
- EUDAMED 597bdc35-8b09-4155-b6a1-96e40188c87b 61 fields · synced Jul 29, 2026
- EUDAMED 55a6e3b7-4f4d-4201-aecc-1df128ebe484 61 fields · synced Sep 30, 2026