← Back to catalogue
Pancreatic Amylase Reagent Kit
EUDAMEDClass IVD General (EU MDR)
Ref P-AMY6011Y, P-AMY6012Y, P-AMY6013Y, P-AMY6014Y, P-AMY6015Y, P-AMY6011N, P-AMY6012N, P-AMY6013N, P-AMY6014N, P-AMY6015N
Identity
- Trade Name
- Pancreatic Amylase Reagent Kit EUDAMED
- Device Name
- Pancreatic Amylase Reagent Kit EUDAMED
- Model / Reference
- P-AMY6011Y, P-AMY6012Y, P-AMY6013Y, P-AMY6014Y, P-AMY6015Y, P-AMY6011N, P-AMY6012N, P-AMY6013N, P-AMY6014N, P-AMY6015N EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-P-AMY601C7 EUDAMED
- Basic UDI-DI
- B-P-AMY601C7 EUDAMED
- EMDN Code
- W01010199 ENZYMES - OTHER 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
Pancreatic 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-P-AMY601C7 | 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 (2)
- EUDAMED 2fd32aee-450b-4a71-9fa1-f80fc4593768 61 fields · synced Jun 19, 2026
- EUDAMED 2fd32aee-450b-4a71-9fa1-f80fc4593768-1 61 fields · synced Jun 10, 2026