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5’-Nucleotidase Reagent Kit（enzyme Method）
EUDAMEDClass IVD General (EU MDR)
Ref 3023567Model R1: 1x50mL, R2: 1x25mL, Calibration sample: 1x1mL, Control: 1x1mLRef 3021547Model R1: 1x50mL, R2: 1x25mLRef 3004590Ref 3012550Ref 3021602Ref 3023553Ref 3021198Model R1: 1x50mL, R2: 1x25mL, Calibration sample: 1x1mL
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, Calibration sample: 1x1mL, Control: 1x1mL EUDAMED3023567 EUDAMEDR1: 1x50mL, R2: 1x25mL EUDAMED3021547 EUDAMED3004590 EUDAMED3012550 EUDAMED3021602 EUDAMED3023553 EUDAMEDR1: 1x50mL, R2: 1x25mL, Calibration sample: 1x1mL EUDAMED3021198 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202215827 EUDAMED06925794591913 EUDAMED06942202246388 EUDAMED06942202258688 EUDAMED06925794591906 EUDAMED06942202215810 EUDAMED06942202258671 EUDAMED
- Basic UDI-DI
- B-06942202215827 EUDAMEDB-06925794591913 EUDAMEDB-06942202246388 EUDAMEDB-06942202258688 EUDAMEDB-06925794591906 EUDAMEDB-06942202215810 EUDAMEDB-06942202258671 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.
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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
- 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-06942202215827 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (7)
- EUDAMED 9ed54cb3-2db4-4c92-970b-09e26889734f 61 fields · synced Jul 31, 2026
- EUDAMED bd880a64-89ae-493b-a0f7-1f4f5f145116 61 fields · synced May 17, 2026
- EUDAMED b7e9e225-a3c0-4ff4-b52b-9c5ad5d48c2f 61 fields · synced May 17, 2026
- EUDAMED 3b75c21c-9a2b-448a-8ab9-e55f09fdd887 61 fields · synced May 18, 2026
- EUDAMED 16100db5-609b-44de-88af-52a63fb33eb7 61 fields · synced May 18, 2026
- EUDAMED 5a27e758-28a8-4fa3-80fa-0607b8cb4744 61 fields · synced May 18, 2026
- EUDAMED 5e0e578d-8623-49e8-9372-954d72352d7c 61 fields · synced May 19, 2026