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Asat Bm 100 / Bm 200
EUDAMEDClass B (EU MDR)
Ref 1-208-0300Ref 1-208-0060Ref 1-208-A075
Identity
- Device Name
- ASAT BM 100 / BM 200 EUDAMED
- Model / Reference
- 1-208-0300 EUDAMED1-208-0060 EUDAMED1-208-A075 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05902643961630 EUDAMED05902643961616 EUDAMED05902643961647 EUDAMED
- Basic UDI-DI
- 59026439BBCH208AH EUDAMED
- EMDN Code
- W01010110 ASPARTATE AMINO-TRANSFERASE EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Poland 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
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Category: Total aspartate aminotransferase (AST) IVD, reagent
Asat Bm 100 / Bm 200 by BioMaxima Spółka Akcyjna — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Total aspartate aminotransferase (AST) IVD, reagent.
- GOT (AST) — Cypress Diagnostics · IVD General
- ASPARTATE AMINOTRANSFERASE REAGENT KIT（IFCC METHOD） — DIRUI INDUSTRIAL CO., LTD · IVD General
- AST (SGOT) Kit — KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ · IVD General
- GOT LIQUID R1:4x40, R2:2x20 ml (ΗΙΤ) — Biotechnological Applications Ltd · IVD General
- Aspartate Aminotransferase Kit( IFCC Method) — Coei Biotech Co.Ltd. · IVD General
- Aspartate Aminotransferase (AST) — KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ · IVD General
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class II
- aminotransferase — C.P.M. COMPAGNIA PER LA MEDICINA S.R.L. · IVD General
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 | 59026439BBCH208AH | Class B | Active |
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Manufacturer
- Manufacturer
- BioMaxima Spółka Akcyjna
- EUDAMED SRN
- PL-MF-000039473
Sources (3)
- EUDAMED a2a0f133-4eb2-4a52-b5ed-9525562a0456 61 fields · synced Jul 29, 2026
- EUDAMED ffeaf70d-e94d-4402-b893-e800114f26c9 61 fields · synced May 18, 2026
- EUDAMED 466e7f3c-9dff-4fa4-8add-72f0b5458584 61 fields · synced May 18, 2026