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Protex
EUDAMEDClass I (EU MDR)
Ref EP05Model POWDER FREE LATEX EXAMINATION GLOVE
Identity
- Trade Name
- Protex EUDAMED
- Device Name
- POWDER FREE LATEX EXAMINATION GLOVE EUDAMED
- Model / Reference
- POWDER FREE LATEX EXAMINATION GLOVE EUDAMEDEP05 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09555710001737 EUDAMED
- Basic UDI-DI
- 955571000OCFTLFC EUDAMED
- EMDN Code
- T010201 LATEX EXAMINATION / TREATMENT GLOVES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Greece 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
Protex by Axg 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 | 955571000OCFTLFC | Class I | Active |
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Manufacturer
- Manufacturer
- Axg Industries Sdn Bhd
- EUDAMED SRN
- MY-MF-000018723
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 5df5ea88-d6af-432b-b48c-a560c5a641e0 61 fields · synced Jun 19, 2026