Identity
- Trade Name
- EXS Magnum (Sakalas) EUDAMEDEXS Magnum EUDAMED
- Device Name
- Non-Medicated Natural Latex Condoms EUDAMED
- Model / Reference
- QA-224 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09556807401003 EUDAMED29556807431103 EUDAMED19556807561216 EUDAMED19556807420995 EUDAMED19556807461110 EUDAMED09556807401607 EUDAMED09556807501222 EUDAMED29556807480989 EUDAMED
- Basic UDI-DI
- 9556807CD001UF EUDAMED
- Direct Marketing DI
- 09556807401003 EUDAMED29556807431103 EUDAMED19556807561216 EUDAMED19556807420995 EUDAMED19556807461110 EUDAMED09556807401607 EUDAMED09556807501222 EUDAMED29556807480989 EUDAMED
- EMDN Code
- U110101 CONDOMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Northern Ireland EUDAMEDGermany 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 Magnum (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 |
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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 (8)
- EUDAMED 88d58b59-cdfa-4f31-a1b7-38b40c24cc02 61 fields · synced Aug 3, 2026
- EUDAMED 05a587d1-f900-4ffe-86fb-c12f48b11082 61 fields · synced May 17, 2026
- EUDAMED b2c729f4-5ab5-4854-a83f-d85f9bb85e3e 61 fields · synced May 17, 2026
- EUDAMED 6061eb79-e8e5-403c-b6d2-9d86b8cf4d7c 61 fields · synced May 17, 2026
- EUDAMED 08f5e32c-1a68-443c-87a9-6dbcfc7c7f84 61 fields · synced May 17, 2026
- EUDAMED 9e67c83b-fbf4-48d9-b93a-9e259fbf00f8 61 fields · synced May 18, 2026
- EUDAMED c98a9b84-4126-4adb-ab60-faf3f1eeba8a 61 fields · synced May 19, 2026
- EUDAMED c3732524-ee5f-4c87-92ec-b1a04e5c5a4e 61 fields · synced May 19, 2026