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Natural rubber latex male condoms
EUDAMEDClass IIb (EU MDR)
Ref EN ISO 4074Model 54±2mm
Identity
- Trade Name
- Natural rubber latex male condoms EUDAMED
- Device Name
- Natural rubber latex EUDAMED
- Model / Reference
- 54±2mm EUDAMEDEN ISO 4074 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950570784968 EUDAMED
- Basic UDI-DI
- B-06950570784968 EUDAMED
- EMDN Code
- U110101 CONDOMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Natural rubber latex male condoms by Dongtai Biomed Industrial Co., LTD — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06950570784968 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Dongtai Biomed Industrial Co., LTD
- EUDAMED SRN
- CN-MF-000021604
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 15ebbf05-4187-4889-b591-456729fa273e 61 fields · synced Jun 18, 2026