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Amylase Reagent Kit
EUDAMEDClass IVD General (EU MDR)
Ref AMY6011Y, AMY6012Y, AMY6013Y, AMY6014Y, AMY6015Y, AMY6011N, AMY6012N, AMY6013N, AMY6014N, AMY6015N
Identity
- Trade Name
- Amylase Reagent Kit EUDAMED
- Device Name
- Amylase Reagent Kit EUDAMED
- Model / Reference
- AMY6011Y, AMY6012Y, AMY6013Y, AMY6014Y, AMY6015Y, AMY6011N, AMY6012N, AMY6013N, AMY6014N, AMY6015N EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-AMY601CN EUDAMED
- Basic UDI-DI
- B-AMY601CN EUDAMED
- EMDN Code
- W01010107 AMYLASE - TOTAL 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
Amylase 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-AMY601CN | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Aichek Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000028093
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (2)
- EUDAMED 3ee46737-5daa-438b-8279-bc4c0cbe2b3e 61 fields · synced Jul 8, 2026
- EUDAMED 3ee46737-5daa-438b-8279-bc4c0cbe2b3e-1 61 fields · synced Jun 9, 2026