← Back to catalogue
AMA-M2 IgG CLIA Microparticles
EUDAMEDClass B (EU MDR)
Ref CMQ2405Model AutoLumo analyzerRef CMQ2408Ref CMQ2403
Identity
- Trade Name
- AMA-M2 IgG CLIA Microparticles EUDAMED
- Model / Reference
- AutoLumo analyzer EUDAMEDCMQ2405 EUDAMEDCMQ2408 EUDAMEDCMQ2403 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942359545785 EUDAMED06942359513418 EUDAMED06942359545761 EUDAMED
- Basic UDI-DI
- 697015090000316HE EUDAMED
- EMDN Code
- W0102100702 ANTI-MITOCHONDRIAL ANTIBODIES EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- France EUDAMEDFinland 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
AMA-M2 IgG CLIA Microparticles by Autobio Diagnostics Co., Ltd. — 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 | 697015090000316HE | Class B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Autobio Diagnostics Co., Ltd.
- EUDAMED SRN
- CN-MF-000003348
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (3)
- EUDAMED e0ca528f-4671-4ca9-a21b-05839bd9e1c3 61 fields · synced Jul 26, 2026
- EUDAMED c4a06090-339d-4b09-84e4-f01e13f9f1a4 61 fields · synced May 18, 2026
- EUDAMED 8b00b0ca-0359-4396-b04d-bdd98c18cffa 61 fields · synced May 19, 2026