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Glucose Reagent Kit(hexokinase Method)
EUDAMEDClass IVD General (EU MDR)
Ref 3021699Model R1: 4x50mL, R2: 2x25mL，Calibration sample: 2mL
Identity
- Trade Name
- GLUCOSE REAGENT KIT(HEXOKINASE METHOD) EUDAMED
- Device Name
- GLUCOSE REAGENT KIT(HEXOKINASE METHOD) EUDAMED
- Model / Reference
- R1: 4x50mL, R2: 2x25mL，Calibration sample: 2mL EUDAMED3021699 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794593047 EUDAMED
- Basic UDI-DI
- B-06925794593047 EUDAMED
- EMDN Code
- W01010213 GLUCOSE 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
Glucose Reagent Kit(hexokinase Method) by Dirui Industrial Co., Ltd — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06925794593047 | 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 (1)
- EUDAMED aafcd7b1-dc76-4aaa-ba5f-903eabac63c0 61 fields · synced Jun 18, 2026