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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, Ribs
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 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925634024281 EUDAMED
- Basic UDI-DI
- 69256340MLC3H EUDAMED
- Direct Marketing DI
- 06925634024281 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 (1)
- EUDAMED cd49680a-fe4e-421e-8375-70c2db0bfa92 61 fields · synced Jun 18, 2026