← Back to catalogue
α-L-Fucosidase Reagent Kit
EUDAMEDClass IVD General (EU MDR)
Ref AFU6011Y, AFU6012Y, AFU6013Y, AFU6014Y, AFU6015Y, AFU6011N, AFU6012N, AFU6013N, AFU6014N, AFU6015N
Identity
- Trade Name
- α-L-Fucosidase Reagent Kit EUDAMED
- Device Name
- α-L-Fucosidase Reagent Kit EUDAMED
- Model / Reference
- AFU6011Y, AFU6012Y, AFU6013Y, AFU6014Y, AFU6015Y, AFU6011N, AFU6012N, AFU6013N, AFU6014N, AFU6015N EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-AFU6019D EUDAMED
- Basic UDI-DI
- B-AFU6019D EUDAMED
- EMDN Code
- W0102039018 ALPHA-FUCOSIDASE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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 by Hangzhou Aichek Medical Technology 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-AFU6019D | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hangzhou Aichek Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000028093
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (3)
- EUDAMED 8aab27f7-8e4f-48fb-a4d6-9138388583b3 61 fields · synced Jun 19, 2026
- EUDAMED 8aab27f7-8e4f-48fb-a4d6-9138388583b3-1 61 fields · synced Jun 10, 2026
- EUDAMED 8aab27f7-8e4f-48fb-a4d6-9138388583b3-2 61 fields · synced Jun 10, 2026