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Ischemia Modified Albumin (IMA) Test Kit(Colorimetric)
EUDAMEDClass IVD General (EU MDR)
Ref Calibrator：1mL×2（91039）Ref R1:20mL×4 R2:10mL×4（709）Ref R1:40mL×2 R2:20mL×2（701）Ref R1:20mL×1 R2:10mL×1（702）
Identity
- Trade Name
- Ischemia Modified Albumin (IMA) Test Kit(Colorimetric) EUDAMED
- Device Name
- Ischemia Modified Albumin (IMA) Test Kit(Colorimetric) EUDAMED
- Model / Reference
- Calibrator：1mL×2（91039） EUDAMEDR1:20mL×4 R2:10mL×4（709） EUDAMEDR1:40mL×2 R2:20mL×2（701） EUDAMEDR1:20mL×1 R2:10mL×1（702） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971674868057 EUDAMED06971674869238 EUDAMED06971674869221 EUDAMED06971674869245 EUDAMED
- Basic UDI-DI
- B-06971674868057 EUDAMEDB-06971674869238 EUDAMEDB-06971674869221 EUDAMEDB-06971674869245 EUDAMED
- EMDN Code
- W01021309 ISCHEMIA MODIFIED ALBUMIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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) Test Kit(Colorimetric) by Biobase Biodustry(Shandong) Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-06971674868057 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biobase Biodustry(Shandong) Co., Ltd.
- EUDAMED SRN
- CN-MF-000025015
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (4)
- EUDAMED fe6fcaa4-2999-4f30-abd3-90826572c576 61 fields · synced Jul 29, 2026
- EUDAMED 6b9c5abf-003e-45da-a272-a820d7539d53 61 fields · synced May 17, 2026
- EUDAMED 9bbaa413-d487-4d05-b1c0-5dd2a3a7d384 61 fields · synced May 18, 2026
- EUDAMED a4391393-89e9-416e-b099-118fe291731b 61 fields · synced May 18, 2026