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Ganzo Juice 72 pcs
EUDAMEDClass IIb (EU MDR)
Ref ELT 016, ELT 017, ELT 018Model Plain
Identity
- Trade Name
- Ganzo Juice 72 pcs EUDAMED
- Device Name
- Natural Rubber Latex Male Condom EUDAMED
- Model / Reference
- Plain EUDAMEDELT 016, ELT 017, ELT 018 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551024780085 EUDAMED
- Basic UDI-DI
- 955410035270PLAINWN EUDAMED
- Direct Marketing DI
- 09551024780085 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 Juice 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 (2)
- EUDAMED 4a4c03e6-f76e-4e50-8679-4169b2e42116 61 fields · synced Jul 10, 2026
- EUDAMED 4a4c03e6-f76e-4e50-8679-4169b2e42116-1 61 fields · synced Jun 9, 2026