Identity
- Trade Name
- My Lubie Extra Large EUDAMED
- Device Name
- Non-Medicated Natural Latex Condoms EUDAMED
- Model / Reference
- QA-224 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 19556807550050 EUDAMED09556807560069 EUDAMED29556807580047 EUDAMED
- Basic UDI-DI
- 9556807CD001UF EUDAMED
- Direct Marketing DI
- 19556807550050 EUDAMED09556807560069 EUDAMED29556807580047 EUDAMED
- EMDN Code
- U110101 CONDOMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France 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
My Lubie Extra Large 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 (3)
- EUDAMED d9902e27-b7be-4651-a0c8-a454abac368e 61 fields · synced Jul 14, 2026
- EUDAMED 72f3c04a-2df6-4033-a7fd-810c31cdd967 61 fields · synced May 17, 2026
- EUDAMED aeaf6510-ee2b-4895-85c2-406bd8e6f69f 61 fields · synced May 19, 2026