Identity
- Trade Name
- EXS Regular (Sakalas) EUDAMED
- Device Name
- Non-Medicated Natural Latex Condoms EUDAMED
- Model / Reference
- QA-224 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 19556807461172 EUDAMED29556807481047 EUDAMED19556807421053 EUDAMED09556807401188 EUDAMED
- Basic UDI-DI
- 9556807CD001UF EUDAMED
- Direct Marketing DI
- 19556807461172 EUDAMED29556807481047 EUDAMED19556807421053 EUDAMED09556807401188 EUDAMED
- EMDN Code
- U110101 CONDOMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Northern Ireland 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
EXS Regular (Sakalas) 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 |
Is this your device? Claim it to add documentation and request validation.
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 b09ebed2-689d-4ab7-b8d3-bde73bb3f665 61 fields · synced Jul 31, 2026
- EUDAMED ada03fb7-62e6-40d2-8da7-58467c8b1848 61 fields · synced May 16, 2026
- EUDAMED 07cf02ab-93f7-4e5d-966c-2b6d76cccf75 61 fields · synced May 19, 2026
- EUDAMED e57f9015-9e21-4c47-b35c-bec50cbf39e1 61 fields · synced May 19, 2026