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5′-Nucleotidase(5′-NT) Test Kit (Peroxidase Assay)
EUDAMEDClass IVD General (EU MDR)
Ref "REF: U87282030M, U87289040M, U87285020M, U87211020M, U87220040M"
Identity
- Device Name
- 5′-Nucleotidase(5′-NT) Test Kit (Peroxidase Assay) EUDAMED
- Model / Reference
- "REF: U87282030M, U87289040M, U87285020M, U87211020M, U87220040M" EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-6-97B EUDAMED
- Basic UDI-DI
- B-6-97B 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
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
Category: 5-Nucleotidase IVD, reagent
5′-Nucleotidase(5′-NT) Test Kit (Peroxidase Assay) by URIT Medical Electronic Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
Similar devices
Also classified as 5-Nucleotidase IVD, reagent.
- 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
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
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-6-97B | 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 2ce39f9f-3bf3-44fe-8311-97e826752001-1 61 fields · synced Jul 16, 2026
- EUDAMED 2ce39f9f-3bf3-44fe-8311-97e826752001-2 61 fields · synced Jul 16, 2026