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5’-Nucleotidase (5'-NT) Assay Kit （Peroxidase Method)
EUDAMEDClass IVD General (EU MDR)
Ref R1: 2×40 mL, R2: 2×20 mL
Identity
- Device Name
- 5’-Nucleotidase (5'-NT) Assay Kit （Peroxidase Method) EUDAMED
- Model / Reference
- R1: 2×40 mL, R2: 2×20 mL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974760129704 EUDAMED
- Basic UDI-DI
- B-06974760129704 EUDAMED
- EMDN Code
- W01010101 5'-NUCLEOTIDASE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria 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
Category: 5-Nucleotidase IVD, reagent
5’-Nucleotidase (5'-NT) Assay Kit （Peroxidase Method) by Shenzhen AmTech Bioengineering Ltd., Inc. — Class IVD General — IVDD — listed in EUDAMED
Similar devices
Also classified as 5-Nucleotidase IVD, reagent.
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- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
- 5′-Nucleotidase (5'-NT) — Maccura Biotechnology Co., Ltd. · IVD General
- 5′-Nucleotidase (5'-NT) — Maccura Biotechnology Co., Ltd. · IVD General
- 5′-Nucleotidase Kit（Enzymatic Colorimetric Method） — Shenzhen Mindray Bio-Medical Electronics Co.,LTD · Class B
- 5′-Nucleotidase Kit（Enzymatic Colorimetric Method） — Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Class B
- 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-06974760129704 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen AmTech Bioengineering Ltd., Inc.
- EUDAMED SRN
- CN-MF-000043067
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (3)
- EUDAMED 113490e4-5c05-44c1-b91d-20979977aff7 61 fields · synced Jul 18, 2026
- EUDAMED 113490e4-5c05-44c1-b91d-20979977aff7-1 61 fields · synced Jun 10, 2026
- EUDAMED 113490e4-5c05-44c1-b91d-20979977aff7-2 61 fields · synced Jun 10, 2026