Identity
- Trade Name
- Vitalis Premium Sensation EUDAMED
- Device Name
- Non-Medicated Natural Latex Condoms EUDAMED
- Model / Reference
- QA-224 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 19556807452705 EUDAMED19556807450749 EUDAMED09556807402383 EUDAMED29556807430731 EUDAMED29556807472373 EUDAMED29556807482693 EUDAMED09556807452715 EUDAMED
- Basic UDI-DI
- 9556807CD001UF EUDAMED
- Direct Marketing DI
- 19556807452705 EUDAMED19556807450749 EUDAMED09556807402383 EUDAMED29556807430731 EUDAMED29556807472373 EUDAMED29556807482693 EUDAMED09556807452715 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 Sensation 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 (7)
- EUDAMED 0a23f699-6856-4aa5-9c54-c771763de637 61 fields · synced Jul 25, 2026
- EUDAMED dfbe6d09-ccab-40cd-b688-1151b384d596 61 fields · synced May 17, 2026
- EUDAMED 9600d879-dd9a-426c-8b2e-5629ea84c838 61 fields · synced May 17, 2026
- EUDAMED 542d5c55-583a-4021-8f0f-cd8e2c0ae5c4 61 fields · synced May 19, 2026
- EUDAMED b743bfee-aab6-4884-86b6-266406ec76e9 61 fields · synced May 19, 2026
- EUDAMED a2ff3d9a-94a1-420d-8a7f-7ee8bda83387 61 fields · synced May 19, 2026
- EUDAMED 5e444186-c931-4e0b-a9b8-aea4d9b68874 61 fields · synced May 19, 2026