Identity
- Trade Name
- AXGLOVE,EP04 EUDAMED
- Device Name
- Powdered Latex Examination Glove, Non-Sterile EUDAMED
- Model / Reference
- PB (G4) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 95557100017066 EUDAMED
- Basic UDI-DI
- 955571000170654 EUDAMED
- Direct Marketing DI
- 95557100017066 EUDAMED
- EMDN Code
- T010201 LATEX EXAMINATION / TREATMENT GLOVES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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
Axglove, Ep04 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 | 955571000170654 | 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 9005e36a-ca52-408b-909a-adfce4515567 61 fields · synced Jun 18, 2026