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Alpha-L-Fucosidase (AFU) Test Kit (CNPF Substrate Method)
EUDAMEDClass IVD General (EU MDR)
Ref R：20mL×2(702018)Ref R：60mL×2(701018)Ref Quality Control(Level 1)1mL×1 Quality Control（Level 2）1mL×1(92003)Ref 06936895300038Ref Calibrator（(Level 1)）1mL×1(91074)Model Calibrator(Level 1)1mL×1(91074)
Identity
- Trade Name
- Alpha-L-Fucosidase (AFU) Test Kit (CNPF Substrate Method) EUDAMED
- Device Name
- Alpha-L-Fucosidase (AFU) Test Kit (CNPF Substrate Method) EUDAMED
- Model / Reference
- R：20mL×2(702018) EUDAMEDR：60mL×2(701018) EUDAMEDQuality Control(Level 1)1mL×1 Quality Control（Level 2）1mL×1(92003) EUDAMED06936895300038 EUDAMEDCalibrator(Level 1)1mL×1(91074) EUDAMEDCalibrator（(Level 1)）1mL×1(91074) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936895300021 EUDAMED06936895300045 EUDAMED06936895300069 EUDAMED06936895300038 EUDAMED06936895300052 EUDAMED
- Basic UDI-DI
- B-06936895300021 EUDAMEDB-06936895300045 EUDAMEDB-06936895300069 EUDAMEDB-06936895300038 EUDAMEDB-06936895300052 EUDAMED
- EMDN Code
- W01010199 ENZYMES - OTHER 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
Alpha-L-Fucosidase (AFU) Test Kit (CNPF Substrate Method) 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-06936895300021 | 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 (5)
- EUDAMED 092e7087-517d-4d9d-9c0c-ad3c3b70502e 61 fields · synced Oct 6, 2026
- EUDAMED 22097646-9e19-4f80-9a3a-ad349f49fcd6 61 fields · synced May 17, 2026
- EUDAMED 4c46d262-0eaa-4aaf-a150-5a705b31491d 61 fields · synced May 17, 2026
- EUDAMED 7fe55e8f-29f0-4f91-be46-878fd96ae161 61 fields · synced May 18, 2026
- EUDAMED 48f5bbd9-a623-4335-a052-a1516d53621a 61 fields · synced May 19, 2026