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5′-Nucleotidase Kit（Enzymatic Colorimetric Method）
EUDAMEDClass B (EU MDR)
Ref 105-026283-00Model 105-003176-00、105-003119-00、105-003124-00、105-026281-00、105-026282-00、105-026283-00、105-020475-00、105-003688-00
Identity
- Trade Name
- 5′-Nucleotidase Kit（Enzymatic Colorimetric Method） EUDAMED
- Device Name
- 5’-Nucleotidase Kit (Enzymatic Colorimetric Method)、5’-NT Control、5’-NT Calibrator EUDAMED
- Model / Reference
- 105-003176-00、105-003119-00、105-003124-00、105-026281-00、105-026282-00、105-026283-00、105-020475-00、105-003688-00 EUDAMED105-026283-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06903053011556 EUDAMED
- Basic UDI-DI
- 6944904000435-NT*******ZV EUDAMED
- EMDN Code
- W01010101 5'-NUCLEOTIDASE EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Germany 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
New Device
No
EUDAMED
Category: 5-Nucleotidase IVD, reagent
5′-Nucleotidase Kit（Enzymatic Colorimetric Method） by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. — Class B — IVDR — listed in EUDAMED
Similar devices
Also classified as 5-Nucleotidase IVD, reagent.
- 5′-Nucleotidase(5′-NT) Test Kit (Peroxidase Assay) — URIT Medical Electronic Co.,Ltd. · IVD General
- 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
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
- 5’-NUCLEOTIDASE REAGENT KIT（ENZYME METHOD） — DIRUI INDUSTRIAL CO., LTD · IVD General
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 6944904000435-NT*******ZV | Class B | Active |
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Manufacturer
- Manufacturer
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- EUDAMED SRN
- CN-MF-000014156
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED befa7ba9-36ec-436c-8aa6-5feb22ad368f 61 fields · synced Jun 19, 2026