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Adenosine Deaminase (ADA)Test Kit (Enzymatic)
EUDAMEDClass IVD General (EU MDR)
Ref Calibrator:1mL×1（91006）Ref R1:20mL×1 R2:10mL×1（702）Ref Quality Control:1mL×1（92005）Ref R1:50mL×2 R2:25mL×2（713）Ref R1:40mL×2 R2:20mL×2（701）Ref R1:50mL×2 R2:25mL×2（700）
Identity
- Trade Name
- Adenosine Deaminase (ADA)Test Kit (Enzymatic) EUDAMED
- Device Name
- Adenosine Deaminase (ADA)Test Kit (Enzymatic) EUDAMEDAdenosine Deaminase (ADA)Test Kit (Enzymatic） EUDAMED
- Model / Reference
- Calibrator:1mL×1（91006） EUDAMEDR1:20mL×1 R2:10mL×1（702） EUDAMEDQuality Control:1mL×1（92005） EUDAMEDR1:50mL×2 R2:25mL×2（713） EUDAMEDR1:40mL×2 R2:20mL×2（701） EUDAMEDR1:50mL×2 R2:25mL×2（700） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971674867784 EUDAMED06971674863236 EUDAMED06971674868200 EUDAMED06971674863250 EUDAMED06971674863212 EUDAMED06971674863205 EUDAMED
- Basic UDI-DI
- B-06971674867784 EUDAMEDB-06971674863236 EUDAMEDB-06971674868200 EUDAMEDB-06971674863250 EUDAMEDB-06971674863212 EUDAMEDB-06971674863205 EUDAMED
- EMDN Code
- W0102019010 ADENOSINE DEAMINASE 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
Adenosine Deaminase (ADA)Test Kit (Enzymatic) 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-06971674867784 | 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 (6)
- EUDAMED 9cad0e53-4d24-4d0d-925e-5550d6965c92 61 fields · synced Oct 6, 2026
- EUDAMED 934f7e8d-1dd9-4c73-b525-7aaa4e138bb5 61 fields · synced May 17, 2026
- EUDAMED 0cb1d287-bf94-48fe-a7f3-8a85b5b981eb 61 fields · synced May 17, 2026
- EUDAMED 4999304b-979b-4579-9baa-7ff68d43779e 61 fields · synced May 17, 2026
- EUDAMED 055d367b-4b8d-49a4-9f03-a1febca4a63c 61 fields · synced May 18, 2026
- EUDAMED 78d7bce5-124a-4a21-97f6-2b1f3edf5723 61 fields · synced May 19, 2026