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Acmex Hepatitis B Surface Antigen (HBsAg) Test
EUDAMEDClass D (EU MDR)
Ref AM02-01-322P25Model Cassette
Identity
- Trade Name
- Acmex Hepatitis B Surface Antigen (HBsAg) Test EUDAMED
- Device Name
- Hepatitis B Surface Antigen (HBsAg) Test EUDAMED
- Model / Reference
- Cassette EUDAMEDAM02-01-322P25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00628347560928 EUDAMED
- Basic UDI-DI
- 62834756AL0201025Z EUDAMED
- EMDN Code
- W0105090201 HBSAG - RT & POC EUDAMED
Classification
- Device Class
- Class D EUDAMED
- Market of Registration
- Hungary EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Acmex Hepatitis B Surface Antigen (HBsAg) Test by Artron Laboratories Inc. — Class D — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 62834756AL0201025Z | Class D | Active |
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Manufacturer
- Manufacturer
- Artron Laboratories Inc.
- EUDAMED SRN
- CA-MF-000028974
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 188e48bb-d72a-4936-9f46-292385d40d33 61 fields · synced Jul 18, 2026