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ABX Minotrol 16
EUDAMEDClass B (EU MDR)
Ref 1300135999Model 2042202Ref 1212042208Ref 1300135997Ref 1212042209Ref 1212042202
Identity
- Trade Name
- ABX Minotrol 16 EUDAMED
- Device Name
- ABX Minotrol 16 EUDAMED
- Model / Reference
- 2042202 EUDAMED1300135999 EUDAMED1212042208 EUDAMED1300135997 EUDAMED1212042209 EUDAMED1212042202 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03610230009673 EUDAMED03610230008515 EUDAMED03610230009666 EUDAMED03610230008539 EUDAMED03610230008522 EUDAMED
- Basic UDI-DI
- 361023minotrol16BH EUDAMED
- EMDN Code
- W0103010503 MULTILEVEL BLOOD CONTROLS EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
ABX Minotrol 16 by Horiba Abx Sas — Class B — 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 | 361023minotrol16BH | Class B | Active |
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Manufacturer
- Manufacturer
- Horiba Abx Sas
- EUDAMED SRN
- FR-MF-000000320
Sources (5)
- EUDAMED 319c131b-7dc3-4eab-a863-1c7b0e759069 61 fields · synced Sep 17, 2026
- EUDAMED f9500cb3-c7d6-486b-abdc-6007e7cfa1fa 61 fields · synced May 16, 2026
- EUDAMED f67afa0f-8042-4864-b9b3-094fc0f29649 61 fields · synced May 18, 2026
- EUDAMED 4c38b4b0-5503-4b69-8abb-c87661449995 61 fields · synced May 18, 2026
- EUDAMED fd43da9a-88ea-4fc7-9d4f-438ad8cbbeed 61 fields · synced May 18, 2026