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Pancreatic Amylase Reagent Kit (EPS Substrate Method)
EUDAMEDClass IVD General (EU MDR)
Ref "REF: U86282040M, U86289060M, U86285020M, U86211020M, U86220060M"
Identity
- Device Name
- Pancreatic Amylase Reagent Kit (EPS Substrate Method) EUDAMED
- Model / Reference
- "REF: U86282040M, U86289060M, U86285020M, U86211020M, U86220060M" EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-6-28AG EUDAMED
- Basic UDI-DI
- B-6-28AG EUDAMED
- EMDN Code
- W01010108 AMYLASE ISOENZYMES EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
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 (EPS Substrate Method) by URIT Medical Electronic Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-6-28AG | Class IVD General | Active |
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Manufacturer
- Manufacturer
- URIT Medical Electronic Co., Ltd.
- EUDAMED SRN
- CN-MF-000011840
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 1f66fedc-665b-4d2b-84bb-28b7638833b2-1 61 fields · synced Jul 21, 2026
- EUDAMED 1f66fedc-665b-4d2b-84bb-28b7638833b2-2 61 fields · synced Jul 21, 2026