Identity
- Trade Name
- RELEAF EUDAMED
- Device Name
- Non-Medicated Natural Latex Condoms EUDAMED
- Model / Reference
- QA-224 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 29556807460684 EUDAMED09556807400716 EUDAMED29556807410702 EUDAMED09556807400693 EUDAMED
- Basic UDI-DI
- 9556807CD001UF EUDAMED
- Direct Marketing DI
- 29556807460684 EUDAMED09556807400716 EUDAMED29556807410702 EUDAMED09556807400693 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
Releaf 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 7d1e90de-ef1e-456e-86d0-342593edaf20 61 fields · synced Aug 2, 2026
- EUDAMED 49bc4c9a-48da-4a7c-aebc-8ca632bb4a80 61 fields · synced May 17, 2026
- EUDAMED ab07382b-5c7f-40e6-ba2b-9bb061749be3 61 fields · synced May 17, 2026
- EUDAMED 496c84f8-6817-4bba-9262-21fed38f24f2 61 fields · synced May 17, 2026