Identity
- Trade Name
- Vitalis Premium Natural EUDAMED
- Device Name
- Non-Medicated Natural Latex Condoms EUDAMED
- Model / Reference
- QA-224 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 19556807452811 EUDAMED09556807402260 EUDAMED19556807452613 EUDAMED09556807402734 EUDAMED09556807452821 EUDAMED29556807482808 EUDAMED19556807482252 EUDAMED09556807452623 EUDAMED
- Basic UDI-DI
- 9556807CD001UF EUDAMED
- Direct Marketing DI
- 19556807452811 EUDAMED09556807402260 EUDAMED19556807452613 EUDAMED09556807402734 EUDAMED09556807452821 EUDAMED29556807482808 EUDAMED19556807482252 EUDAMED09556807452623 EUDAMED
- EMDN Code
- U110101 CONDOMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany 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
Vitalis Premium Natural 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 (8)
- EUDAMED 6e01e590-6f43-43e6-ac3e-6d357c2b1bc3 61 fields · synced Aug 4, 2026
- EUDAMED 3d9d74d5-03b5-4ee5-a124-9f06f92bd309 61 fields · synced May 16, 2026
- EUDAMED b21c1d75-294f-487f-b511-d6e7c624a7ef 61 fields · synced May 16, 2026
- EUDAMED 3a7a02aa-191e-4440-bd74-1172797b9c16 61 fields · synced May 16, 2026
- EUDAMED b407b923-7daa-4c59-8bde-2a96ac35f15d 61 fields · synced May 17, 2026
- EUDAMED 623703e3-fc39-49e6-8adc-e8fe5fc93b56 61 fields · synced May 19, 2026
- EUDAMED 534392cd-bbb4-4dc8-bc98-ebf939a30851 61 fields · synced May 19, 2026
- EUDAMED 3181f1c6-6a17-4122-b3c9-f143400c2ca3 61 fields · synced May 19, 2026