Identity
- Trade Name
- Vitalis Premium Strong EUDAMED
- Device Name
- Non-Medicated Natural Latex Condoms EUDAMED
- Model / Reference
- QA-224 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 29556807472960 EUDAMED29556807482860 EUDAMED09556807452883 EUDAMED29556807432667 EUDAMED09556807402970 EUDAMED
- Basic UDI-DI
- 9556807CD001UF EUDAMED
- Direct Marketing DI
- 29556807472960 EUDAMED29556807482860 EUDAMED09556807452883 EUDAMED29556807432667 EUDAMED09556807402970 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 Strong 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 (5)
- EUDAMED dbd2b233-5d77-4cde-a6ea-b81cbbd2cecf 61 fields · synced Jul 31, 2026
- EUDAMED ef6a7477-7292-4104-9dbf-0782667872f0 61 fields · synced May 17, 2026
- EUDAMED 30cfe99b-9515-407f-9870-3cf228ed531c 61 fields · synced May 17, 2026
- EUDAMED ebab8f8e-738e-444c-b2a5-92aedb615267 61 fields · synced May 17, 2026
- EUDAMED 6b130876-280b-4b62-9d5a-84ef3b2b2152 61 fields · synced May 19, 2026