Identity
- Trade Name
- De Sensitiv EUDAMED
- Device Name
- Non-Medicated Natural Latex Condoms EUDAMED
- Model / Reference
- QA-224 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 19556807324651 EUDAMED09556807304663 EUDAMED09556807304632 EUDAMED19556807354627 EUDAMED
- Basic UDI-DI
- 9556807CD001UF EUDAMED
- Direct Marketing DI
- 19556807324651 EUDAMED09556807304663 EUDAMED09556807304632 EUDAMED19556807354627 EUDAMED
- EMDN Code
- U110101 CONDOMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France 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
De Sensitiv by Richter Rubber Technology Sdn. Bhd. — 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 | 9556807CD001UF | Class IIb | Active |
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Manufacturer
- Manufacturer
- Richter Rubber Technology Sdn Bhd
- EUDAMED SRN
- MY-MF-000023324
- Authorised Representative
- rrt Vertrieb und Service GmbH DE-AR-000021443
Sources (4)
- EUDAMED 60de0330-b9e4-402f-a6d4-02c2f9e95ae6 61 fields · synced Aug 1, 2026
- EUDAMED 18f19b78-f00b-4bc1-a2cd-e39a3dd66fec 61 fields · synced May 17, 2026
- EUDAMED 9a11c3c2-a9dc-4113-81e2-cfaf5c80b6d4 61 fields · synced May 18, 2026
- EUDAMED b6acb61a-6f19-4c58-a2d0-8601f342482b 61 fields · synced May 19, 2026