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5'-Nucleotidase Reagent Kit
EUDAMEDClass IVD General (EU MDR)
Ref 5-NT6011Y, 5-NT6012Y, 5-NT6013Y, 5-NT6014Y, 5-NT6015Y, 5-NT6011N, 5-NT6012N, 5-NT6013N, 5-NT6014N, 5-NT6015N
Identity
- Trade Name
- 5'-Nucleotidase Reagent Kit EUDAMED
- Device Name
- 5'-Nucleotidase Reagent Kit EUDAMED
- Model / Reference
- 5-NT6011Y, 5-NT6012Y, 5-NT6013Y, 5-NT6014Y, 5-NT6015Y, 5-NT6011N, 5-NT6012N, 5-NT6013N, 5-NT6014N, 5-NT6015N EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-5-NT601DR EUDAMED
- Basic UDI-DI
- B-5-NT601DR EUDAMED
- EMDN Code
- W01010101 5'-NUCLEOTIDASE 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
Category: 5-Nucleotidase IVD, reagent
5'-Nucleotidase Reagent Kit by Hangzhou Aichek Medical Technology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as 5-Nucleotidase IVD, reagent.
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- 5′-Nucleotidase Kit（Enzymatic Colorimetric Method） — Shenzhen Mindray Bio-Medical Electronics Co.,LTD · Class B
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- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
- 5’-NUCLEOTIDASE REAGENT KIT（ENZYME METHOD） — DIRUI INDUSTRIAL CO., LTD · IVD General
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-5-NT601DR | 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 c55356c6-c51f-4af7-a91f-7d26703a2903 61 fields · synced Jun 19, 2026
- EUDAMED c55356c6-c51f-4af7-a91f-7d26703a2903-1 61 fields · synced Jun 10, 2026