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Eclipse A1C
EUDAMEDClass IVD General (EU MDR)
Ref S54133, S54144, S54145, S54119
Identity
- Trade Name
- Eclipse A1C EUDAMED
- Device Name
- Eclipse A1C Hemoglobin A1c POC analyzer EUDAMED
- Model / Reference
- S54133, S54144, S54145, S54119 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-47136487600B05F EUDAMED
- Basic UDI-DI
- B-47136487600B05F EUDAMED
- EMDN Code
- W0101060107,W0201060101 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
Eclipse A1C by Apex Biotechnology Corp. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-47136487600B05F | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Apex Biotechnology Corp.
- EUDAMED SRN
- TW-MF-000019773
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 49fb8d6f-1c0e-4002-974f-6fcc2d3fa02e 61 fields · synced Jul 31, 2026
- EUDAMED 49fb8d6f-1c0e-4002-974f-6fcc2d3fa02e-1 61 fields · synced Jun 10, 2026