Identity
- Trade Name
- Primeros classy EUDAMED
- Device Name
- Non-Medicated Natural Latex Condoms EUDAMED
- Model / Reference
- QA-224 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09556807343495 EUDAMED29556807333308 EUDAMED29556807383488 EUDAMED09556807313313 EUDAMED09556807501673 EUDAMED
- Basic UDI-DI
- 9556807CD001UF EUDAMED
- Direct Marketing DI
- 09556807343495 EUDAMED29556807333308 EUDAMED29556807383488 EUDAMED09556807313313 EUDAMED09556807501673 EUDAMED
- EMDN Code
- U110101 CONDOMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Czechia 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
Primeros classy 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 f50d5818-91a1-4215-9973-465d369170b4 61 fields · synced Aug 4, 2026
- EUDAMED a4d8c22c-517e-4b3b-9683-4e1d63e9b272 61 fields · synced May 16, 2026
- EUDAMED 45ff0829-084d-44b2-a105-7320910ba988 61 fields · synced May 16, 2026
- EUDAMED 1ec2b7bf-4423-414d-804b-690330c35fce 61 fields · synced May 16, 2026
- EUDAMED 454cc3d0-c150-4986-8c5e-82a7d8d09ef5 61 fields · synced May 19, 2026