Identity
- Trade Name
- Primeros innocent EUDAMED
- Device Name
- Non-Medicated Natural Latex Condoms EUDAMED
- Model / Reference
- QA-224 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09556807343532 EUDAMED09556807313351 EUDAMED29556807333346 EUDAMED
- Basic UDI-DI
- 9556807CD001UF EUDAMED
- Direct Marketing DI
- 09556807343532 EUDAMED09556807313351 EUDAMED29556807333346 EUDAMED
- EMDN Code
- U110101 CONDOMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Czechia 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
Primeros innocent 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Richter Rubber Technology Sdn Bhd
- EUDAMED SRN
- MY-MF-000023324
- Authorised Representative
- rrt Vertrieb und Service GmbH DE-AR-000021443
Sources (3)
- EUDAMED fcb0cfd3-8edd-4601-95a8-57c21e7d066e 61 fields · synced Jul 15, 2026
- EUDAMED bd7c05b8-083a-46b3-8416-c9b30dc78587 61 fields · synced May 17, 2026
- EUDAMED fa7c9281-ed06-40f1-9e5f-62a6d1bcdd15 61 fields · synced May 19, 2026