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Lipase Reagent Kit
EUDAMEDClass IVD General (EU MDR)
Ref LPS6011Y, LPS6012Y, LPS6013Y, LPS6014Y, LPS6015Y, LPS6011N, LPS6012N, LPS6013N, LPS6014N, LPS6015N
Identity
- Trade Name
- Lipase Reagent Kit EUDAMED
- Device Name
- Lipase Reagent Kit EUDAMED
- Model / Reference
- LPS6011Y, LPS6012Y, LPS6013Y, LPS6014Y, LPS6015Y, LPS6011N, LPS6012N, LPS6013N, LPS6014N, LPS6015N EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-LPS601GU EUDAMED
- Basic UDI-DI
- B-LPS601GU EUDAMED
- EMDN Code
- W01010123 LIPASE 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
Lipase 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-LPS601GU | 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 42975652-086e-4427-a907-b03656542b1b-1 61 fields · synced Jun 19, 2026
- EUDAMED 42975652-086e-4427-a907-b03656542b1b-2 61 fields · synced Jun 19, 2026