Identity
- Trade Name
- Galenika EUDAMED
- Device Name
- Galenika Nitrile Examination Gloves EUDAMED
- Model / Reference
- BRI-T01020204-GLNK EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09555926401123 EUDAMED
- Basic UDI-DI
- 592640T01020204-GLNKT9 EUDAMED
- EMDN Code
- T01020204 NITRILE EXAMINATION / TREATMENT GLOVES EUDAMED
Classification
- Device Class
- Class I EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
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
Galenika by Biomax Rubber Industries Sdn Bhd — Class I — 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 | 592640T01020204-GLNKT9 | Class I | Active |
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Manufacturer
- Manufacturer
- Biomax Rubber Industries Sdn Bhd
- EUDAMED SRN
- MY-MF-000044218
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED b4b783a1-348b-4932-8ece-639891e7963f 61 fields · synced Jun 18, 2026