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Axglove, Ep04
EUDAMEDClass I (EU MDR)
Ref PB (G4)Model POWDERED LATEX EXAMINATION GLOVERef T010201Ref PB(G1)Model Powder Free Nitrile Examination Glove, Non-Sterile.Ref PB (G2)Model POWDER FREE LATEX EXAMINATION GLOVE
Identity
- Trade Name
- AXGLOVE,EP04 EUDAMEDAXGLOVE EUDAMED
- Device Name
- Powdered Latex Examination Glove, Non-Sterile EUDAMEDPOWDERED LATEX EXAMINATION GLOVE EUDAMEDPowder Free Nitrile Examination Glove, Non-Sterile. EUDAMEDPOWDER FREE LATEX EXAMINATION GLOVE EUDAMED
- Model / Reference
- PB (G4) EUDAMEDPOWDERED LATEX EXAMINATION GLOVE EUDAMEDT010201 EUDAMEDPowder Free Nitrile Examination Glove, Non-Sterile. EUDAMEDPB(G1) EUDAMEDPOWDER FREE LATEX EXAMINATION GLOVE EUDAMEDPB (G2) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 95557100017134 EUDAMED95557100016908 EUDAMED95557100000754 EUDAMED95557100016830 EUDAMED95557100001362 EUDAMED95557100001980 EUDAMED95557100017202 EUDAMED
- Basic UDI-DI
- 95557100017134Z EUDAMED95557100016905E EUDAMED955571000PPFTLJJ EUDAMED95557100016835H EUDAMED955571000OCFTN5UPA EUDAMED955571000OCFTLFC EUDAMED95557100017204W EUDAMED
- Direct Marketing DI
- 95557100017134 EUDAMED95557100016908 EUDAMED95557100016830 EUDAMED95557100017202 EUDAMED
- EMDN Code
- T010201 LATEX EXAMINATION / TREATMENT GLOVES EUDAMEDT01020204 NITRILE EXAMINATION / TREATMENT GLOVES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMEDEUDAMED
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 | 95557100017134Z | 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 (7)
- EUDAMED 77f5c339-3edc-4737-a153-2b8e89a5a032 61 fields · synced Jul 27, 2026
- EUDAMED 87f50f74-d365-4b89-80cc-de2b9687afa1 61 fields · synced May 16, 2026
- EUDAMED d8ed23ad-e19e-44a9-ac87-23443cd4def5 61 fields · synced May 16, 2026
- EUDAMED 19e884dc-47ab-4486-a1ec-bf07c0cc3054 61 fields · synced May 17, 2026
- EUDAMED c6575eaa-1f2c-469d-a36b-4cdd0ccb91ab 61 fields · synced May 17, 2026
- EUDAMED 41e1961f-7d6b-4697-a1a7-7f0dd4c811e5 61 fields · synced May 18, 2026
- EUDAMED 639a428d-7b43-40a1-a33c-746cf4cf034f 61 fields · synced May 19, 2026