Identity
- Trade Name
- EXS Ribbed & Dotted (Sakalas) EUDAMED
- Device Name
- Non-Medicated Natural Latex Condoms EUDAMED
- Model / Reference
- QA-224 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 29556807431134 EUDAMED19556807421022 EUDAMED09556807401157 EUDAMED19556807461141 EUDAMED
- Basic UDI-DI
- 9556807CD001UF EUDAMED
- Direct Marketing DI
- 29556807431134 EUDAMED19556807421022 EUDAMED09556807401157 EUDAMED19556807461141 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 Ribbed & Dotted (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 772d95ae-8d3d-41c1-ad87-cec33cb6a744 61 fields · synced Jul 31, 2026
- EUDAMED b03556ab-f101-4e77-87c1-1330d4ca6b1f 61 fields · synced May 17, 2026
- EUDAMED 38c39080-01cb-42e8-9c87-6533327b45f6 61 fields · synced May 18, 2026
- EUDAMED 7c10b420-0d06-483a-a117-5723b9c9032c 61 fields · synced May 19, 2026