Identity
- Trade Name
- Galenika EUDAMED
- Device Name
- Galenika Latex Examination Gloves EUDAMEDGalenika Nitrile Examination Gloves EUDAMED
- Model / Reference
- BRI-T010201-GLNK EUDAMEDBRI-T01020204-GLNK EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09555926401055 EUDAMED09555926401079 EUDAMED09555926401062 EUDAMED09555926401116 EUDAMED
- Basic UDI-DI
- 592640T010201-GLNKHC EUDAMED592640T01020204-GLNKT9 EUDAMED
- EMDN Code
- T010201 LATEX EXAMINATION / TREATMENT GLOVES EUDAMEDT01020204 NITRILE EXAMINATION / TREATMENT GLOVES EUDAMED
Classification
- Device Class
- Class I EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
EUDAMEDEUDAMED
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 | 592640T010201-GLNKHC | 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 (4)
- EUDAMED 1ceb362f-18dc-405b-bad5-40a66467d25d 61 fields · synced Jul 25, 2026
- EUDAMED 46eaa271-d062-451c-94a5-365d6980b0f6 61 fields · synced May 17, 2026
- EUDAMED bf29e74c-f3d2-4631-940f-133a72fab997 61 fields · synced May 17, 2026
- EUDAMED 44d24681-a474-4d24-ad65-50e0df3ca47f 61 fields · synced May 19, 2026