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α-L-Fucosidase Reagent Kit (CNPF Substrate Method)
EUDAMEDClass IVD General (EU MDR)
Ref 3023566Model R:1x50mL, Calibration sample: 1x1mL, Control: 1x1mLRef 3021651Ref 3011623Model R: 1x50mLRef 3011687Model R:1x50mL, Calibration sample: 1mL, Control: 1mL
Identity
- Trade Name
- α-L-Fucosidase Reagent Kit (CNPF Substrate Method) EUDAMED
- Device Name
- α-L-Fucosidase Reagent Kit (CNPF Substrate Method) EUDAMED
- Model / Reference
- R:1x50mL, Calibration sample: 1x1mL, Control: 1x1mL EUDAMED3023566 EUDAMED3021651 EUDAMEDR: 1x50mL EUDAMED3011623 EUDAMEDR:1x50mL, Calibration sample: 1mL, Control: 1mL EUDAMED3011687 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202215773 EUDAMED06925794592064 EUDAMED06942202246395 EUDAMED06942202246401 EUDAMED
- Basic UDI-DI
- B-06942202215773 EUDAMEDB-06925794592064 EUDAMEDB-06942202246395 EUDAMEDB-06942202246401 EUDAMED
- EMDN Code
- W01010199 ENZYMES - OTHER 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
α-L-Fucosidase Reagent Kit (CNPF Substrate Method) by Dirui Industrial 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-06942202215773 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (4)
- EUDAMED 945325e7-fbfb-41eb-b72f-bb16d06a0fd2 61 fields · synced Jul 30, 2026
- EUDAMED 47a03ea1-d52b-4404-b5a0-1f5eb701afc8 61 fields · synced May 17, 2026
- EUDAMED 1ceb2a86-6a5c-472d-9446-a9df777df45e 61 fields · synced May 18, 2026
- EUDAMED c28ed58f-6ebe-4de5-962b-1928b1320b05 61 fields · synced May 19, 2026