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Ischemia Modified Albumin （IMA）Assay Kit （Albumin Cobalt Binding Method）
EUDAMEDClass IVD General (EU MDR)
Ref R1: 2×60 mL, R2: 2×20 mL
Identity
- Device Name
- Ischemia Modified Albumin （IMA）Assay Kit （Albumin Cobalt Binding Method） EUDAMED
- Model / Reference
- R1: 2×60 mL, R2: 2×20 mL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974760129865 EUDAMED
- Basic UDI-DI
- B-06974760129865 EUDAMED
- EMDN Code
- W01021309 ISCHEMIA MODIFIED ALBUMIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
Ischemia Modified Albumin （IMA）Assay Kit （Albumin Cobalt Binding Method） by Shenzhen AmTech Bioengineering Ltd., Inc. — Class IVD General — IVDD — listed in…
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-06974760129865 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen AmTech Bioengineering Ltd., Inc.
- EUDAMED SRN
- CN-MF-000043067
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (3)
- EUDAMED f22e36f1-8eb5-44a2-ab05-19be6c53b888 61 fields · synced Oct 6, 2026
- EUDAMED f22e36f1-8eb5-44a2-ab05-19be6c53b888-1 61 fields · synced Jun 9, 2026
- EUDAMED f22e36f1-8eb5-44a2-ab05-19be6c53b888-2 61 fields · synced Jun 9, 2026