Identity
- Trade Name
- EXS Smiley EUDAMED
- Device Name
- Non-Medicated Natural Latex Condoms EUDAMED
- Model / Reference
- QA-224 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09556807451367 EUDAMED09556807300856 EUDAMED29556807481344 EUDAMED29556807300843 EUDAMED
- Basic UDI-DI
- 9556807CD001UF EUDAMED
- Direct Marketing DI
- 09556807451367 EUDAMED09556807300856 EUDAMED29556807481344 EUDAMED29556807300843 EUDAMED
- EMDN Code
- U110101 CONDOMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Northern Ireland EUDAMEDGermany 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
EXS Smiley 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 9c63394c-0ba4-42a5-97de-ffd1c04cd577 61 fields · synced Jul 24, 2026
- EUDAMED e5fc60c4-444f-4576-92c1-5b35f4658879 61 fields · synced May 19, 2026
- EUDAMED 26c8cc4e-db3c-494c-a232-e42c686abc70 61 fields · synced May 19, 2026
- EUDAMED 8fe6bd6a-3d95-433b-9bf7-ad3efc056a80 61 fields · synced May 19, 2026