Identity
- Device Name
- Natural latex rubber male condoms EUDAMED
- Model / Reference
- PCP5201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16936296750019 EUDAMED
- Basic UDI-DI
- 69362967condom22301FD EUDAMED
- EMDN Code
- U110101 CONDOMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Spain 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
Natural latex rubber male condoms by Shanghai Personage Hygiene Products 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 | 69362967condom22301FD | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shanghai Personage Hygiene Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000035637
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED ce41a67e-8f84-4a52-8c8b-f2de3fb058b1 61 fields · synced Oct 6, 2026