Identity
- Trade Name
- You & Me Macho EUDAMED
- Device Name
- Non-Medicated Natural Latex Condoms EUDAMED
- Model / Reference
- QA-224 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 19556807350681 EUDAMED
- Basic UDI-DI
- 9556807CD001UF EUDAMED
- Direct Marketing DI
- 19556807350681 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
You & Me Macho 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 (1)
- EUDAMED c9032a91-6b47-44a8-a240-eec436378f8a 61 fields · synced Jun 19, 2026