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Amylase (AMY) Assay Kit (CNP-G3 Method)
EUDAMEDClass IVD General (EU MDR)
Ref 113H50TSCRef 113H100TSC
Identity
- Trade Name
- Amylase (AMY) Assay Kit (CNP-G3 Method) EUDAMED
- Device Name
- Amylase (AMY) Assay Kit (CNP-G3 Method) EUDAMED
- Model / Reference
- 113H50TSC EUDAMED113H100TSC EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-113H50TSC2L EUDAMEDD-113H100TSCGF EUDAMED
- Basic UDI-DI
- B-113H50TSC2L EUDAMEDB-113H100TSCGF 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
No
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 (AMY) Assay Kit (CNP-G3 Method) by Yhlo Biotech (nanjing) 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-113H50TSC2L | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Yhlo Biotech (nanjing) Co., Ltd.
- EUDAMED SRN
- CN-MF-000050474
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (2)
- EUDAMED 2c937f08-ba8a-4b81-b076-19d49a7fcc00 61 fields · synced Oct 6, 2026
- EUDAMED 75db3e49-e666-4c5b-b454-ecc8d60c0791 61 fields · synced May 18, 2026