Identity
- Trade Name
- Ganzo Classic 72 pcs EUDAMED
- Device Name
- Natural Rubber Latex Male Condom EUDAMED
- Model / Reference
- Plain EUDAMEDELT 015 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551024780047 EUDAMED
- Basic UDI-DI
- 955410035270PLAINWN EUDAMED
- Direct Marketing DI
- 09551024780047 EUDAMED
- EMDN Code
- U110101 CONDOMS EUDAMED
Classification
- Device Class
- Class IIb 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
Ganzo Classic 72 pcs 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 dbe95eb6-300d-4fa2-8db6-650320fcd92f 61 fields · synced Jun 19, 2026