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Natural Rubber Latex Male Condom
EUDAMEDClass IIb (EU MDR)
Ref ELT 043 - ELT 056Model DottedRef ELT 001 - ELT 035Model Plain
Identity
- Device Name
- Natural Rubber Latex Male Condom EUDAMED
- Model / Reference
- Dotted EUDAMEDELT 043 - ELT 056 EUDAMEDPlain EUDAMEDELT 001 - ELT 035 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09554100448602 EUDAMED09554100448626 EUDAMED
- Basic UDI-DI
- 955410035270DOTTED7J EUDAMED955410035270PLAINWN EUDAMED
- EMDN Code
- U110101 CONDOMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Spain 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
Natural Rubber Latex Male Condom 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 | 955410035270DOTTED7J | 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 (2)
- EUDAMED dc1862b4-fe0a-4660-9ad5-4a9348f3100f 61 fields · synced Jul 15, 2026
- EUDAMED 9136dbca-301e-4dd9-92f5-8d07fdfb796a 61 fields · synced May 18, 2026