Identity
- Trade Name
- Vitalis Premium Super Thin EUDAMED
- Device Name
- Non-Medicated Natural Latex Condoms EUDAMED
- Model / Reference
- QA-224 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09556807402369 EUDAMED19556807450640 EUDAMED29556807430632 EUDAMED09556807452432 EUDAMED09556807450650 EUDAMED29556807472359 EUDAMED19556807452422 EUDAMED
- Basic UDI-DI
- 9556807CD001UF EUDAMED
- Direct Marketing DI
- 09556807402369 EUDAMED19556807450640 EUDAMED29556807430632 EUDAMED09556807452432 EUDAMED09556807450650 EUDAMED29556807472359 EUDAMED19556807452422 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 Super Thin 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 9a23eca2-3571-4d6b-96bf-b1aecf521bd9 61 fields · synced Jul 31, 2026
- EUDAMED 2bc89b60-f0c2-4868-8079-63224b5d2ac8 61 fields · synced May 17, 2026
- EUDAMED ca92363a-883b-4101-8ac5-d9acfbe82d24 61 fields · synced May 18, 2026
- EUDAMED fb5867ab-8529-4db7-824d-124346844b3d 61 fields · synced May 19, 2026
- EUDAMED a1632e03-df4c-4c1d-be6a-439f8b531c83 61 fields · synced May 19, 2026
- EUDAMED 67684ad2-b4ac-4fdb-a71b-ea0a8c09c459 61 fields · synced May 19, 2026
- EUDAMED f52b5511-7f0c-4436-b7a6-8d84158013ae 61 fields · synced May 19, 2026