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Albumin (ALB) Test Kit (BCG )
EUDAMEDClass IVD General (EU MDR)
Ref R:60mL×2（701）Ref R:40mL×4（704）Ref R:40mL×4（715）Ref R:20mL×8（796）Ref R:20mL×2（702）Ref R:70mL×8（795）Ref R:40mL×4（716）Ref R:40mL×4（798）Ref R:40mL×4（793）
Identity
- Trade Name
- Albumin (ALB) Test Kit (BCG ) EUDAMED
- Device Name
- Albumin (ALB) Test Kit (BCG ) EUDAMED
- Model / Reference
- R:60mL×2（701） EUDAMEDR:40mL×4（704） EUDAMEDR:40mL×4（715） EUDAMEDR:20mL×8（796） EUDAMEDR:20mL×2（702） EUDAMEDR:70mL×8（795） EUDAMEDR:40mL×4（716） EUDAMEDR:40mL×4（798） EUDAMEDR:40mL×4（793） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971674862406 EUDAMED06971674862444 EUDAMED06971674862550 EUDAMED06971674862536 EUDAMED06971674862420 EUDAMED06971674862529 EUDAMED06971674862567 EUDAMED06971674862543 EUDAMED06971674862512 EUDAMED
- Basic UDI-DI
- B-06971674862406 EUDAMEDB-06971674862444 EUDAMEDB-06971674862550 EUDAMEDB-06971674862536 EUDAMEDB-06971674862420 EUDAMEDB-06971674862529 EUDAMEDB-06971674862567 EUDAMEDB-06971674862543 EUDAMEDB-06971674862512 EUDAMED
- EMDN Code
- W0102010309 ALBUMIN (IC) INCL. UALBUMIN 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
Albumin (ALB) Test Kit (BCG ) by Biobase Biodustry(Shandong) Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06971674862406 | 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 (9)
- EUDAMED 7f1f2f6f-397d-47ef-809a-f24b6274ddb9 61 fields · synced Oct 6, 2026
- EUDAMED 03cf05d3-9650-4603-8b67-14cef08a3490 61 fields · synced May 17, 2026
- EUDAMED 969475aa-2535-423a-b7ea-9ec8657ace3c 61 fields · synced May 17, 2026
- EUDAMED f0227260-3c73-4093-9c72-4e2cd56a3dd8 61 fields · synced May 17, 2026
- EUDAMED 37911f0a-9e0c-46b7-b0c7-83f15f2864a0 61 fields · synced May 18, 2026
- EUDAMED 9301dff1-3bf1-4d8d-b2cb-041eadf9e751 61 fields · synced May 18, 2026
- EUDAMED c4849c8a-04e4-43e9-8e1a-a78ce8f339a9 61 fields · synced May 18, 2026
- EUDAMED b080ea42-b0ae-4417-bfca-a852a83d97b5 61 fields · synced May 18, 2026
- EUDAMED 3a9fddd6-2122-45a4-86d3-738780d620b4 61 fields · synced May 18, 2026