Identity
- Trade Name
- OEBRE Tutti Frutti EUDAMED
- Device Name
- Natural Rubber Latex Male Condom EUDAMED
- Model / Reference
- Plain EUDAMEDELT 015/T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551024780023 EUDAMED
- Basic UDI-DI
- 955410035270PLAINWN EUDAMED
- Direct Marketing DI
- 09551024780023 EUDAMED
- EMDN Code
- U110101 CONDOMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany 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
OEBRE Tutti Frutti by Eurolatex 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 | 955410035270PLAINWN | Class IIb | Active |
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Manufacturer
- Manufacturer
- Eurolatex Sdn. Bhd.
- EUDAMED SRN
- MY-MF-000003748
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED 48ae54ed-5f62-447d-87d4-4f7aeb43fd18 61 fields · synced Jun 19, 2026