← Back to catalogue
5’-Nucleotidase Reagent Kit（enzyme Method）
EUDAMEDClass IVD General (EU MDR)
Ref 3001695Model R1: 1x50mL, R2: 1x25mL
Identity
- Trade Name
- 5’-NUCLEOTIDASE REAGENT KIT（ENZYME METHOD） EUDAMED
- Device Name
- 5’-NUCLEOTIDASE REAGENT KIT（ENZYME METHOD） EUDAMED
- Model / Reference
- R1: 1x50mL, R2: 1x25mL EUDAMED3001695 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202246371 EUDAMED
- Basic UDI-DI
- B-06942202246371 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
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 Reagent Kit（enzyme Method） by Dirui Industrial Co., Ltd — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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
- 5′-Nucleotidase Kit（Enzymatic Colorimetric Method） — Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Class B
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
- 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-06942202246371 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED b592bc22-c8da-4484-94de-373547cdda8a 61 fields · synced Jun 19, 2026