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Male Latex Condoms
EUDAMEDFDA 510(k)Class 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
- 06925634024274 EUDAMED
- Basic UDI-DI
- 69256340MLC3H EUDAMED
- Direct Marketing DI
- 06925634024274 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 — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K222611 | Class IIb | Active |
| 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 (2)
- EUDAMED 4523bf2e-c052-4e72-9ffe-3ac70f7d3bcb 61 fields · synced Jun 18, 2026
- FDA 510(k) K222611 1 fields · synced May 18, 2026