Identity
- Trade Name
- You & Me Romeo EUDAMED
- Device Name
- Non-Medicated Natural Latex Condoms EUDAMED
- Model / Reference
- QA-224 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 29556807330642 EUDAMED09556807310664 EUDAMED29556807380999 EUDAMED09556807501697 EUDAMED19556807310654 EUDAMED
- Basic UDI-DI
- 9556807CD001UF EUDAMED
- Direct Marketing DI
- 29556807330642 EUDAMED09556807310664 EUDAMED29556807380999 EUDAMED09556807501697 EUDAMED19556807310654 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
You & Me Romeo 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 (5)
- EUDAMED e42e0b5e-0c47-44a9-bcc5-cd187a6e0ea1 61 fields · synced Aug 2, 2026
- EUDAMED 47f37566-f694-4c29-913b-7c7d6508d2ab 61 fields · synced May 18, 2026
- EUDAMED 96d02cbc-4586-4248-94e0-cf0f1b115491 61 fields · synced May 19, 2026
- EUDAMED 017e5588-af80-43ce-87ee-e608201163c7 61 fields · synced May 19, 2026
- EUDAMED 5795e184-530f-4ea7-97cc-cdeef5d77f64 61 fields · synced May 19, 2026