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Glucose Reagent Kit(hexokinase Method)
EUDAMEDClass IVD General (EU MDR)
Ref 3000581Model R1: 2x60mL, R2: 2x15mL, Calibration sample: 2mLRef 3000579Model R1: 4x80mL, R2: 4x20mL, Calibration sample: 2mLRef 3023564Model R1: 4x50mL, R2: 1x50mL，Calibration sample: 2mLRef 3023579Ref 3021539
Identity
- Trade Name
- GLUCOSE REAGENT KIT(HEXOKINASE METHOD) EUDAMED
- Device Name
- GLUCOSE REAGENT KIT(HEXOKINASE METHOD) EUDAMED
- Model / Reference
- R1: 2x60mL, R2: 2x15mL, Calibration sample: 2mL EUDAMED3000581 EUDAMEDR1: 4x80mL, R2: 4x20mL, Calibration sample: 2mL EUDAMED3000579 EUDAMEDR1: 4x50mL, R2: 1x50mL，Calibration sample: 2mL EUDAMED3023564 EUDAMED3023579 EUDAMED3021539 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202259890 EUDAMED06942202259913 EUDAMED06942202216060 EUDAMED06942202216053 EUDAMED06925794593023 EUDAMED
- Basic UDI-DI
- B-06942202259890 EUDAMEDB-06942202259913 EUDAMEDB-06942202216060 EUDAMEDB-06942202216053 EUDAMEDB-06925794593023 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-06942202259890 | 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 (5)
- EUDAMED 94546cc5-db20-4fd1-af00-710d6df8d657 61 fields · synced Sep 17, 2026
- EUDAMED 6548bb33-8eb0-49a6-8826-6b17f42ad254 61 fields · synced May 17, 2026
- EUDAMED 9e4ce872-7ff3-4133-8886-c2508e14ee5f 61 fields · synced Jul 9, 2026
- EUDAMED 7c9d0b55-ca62-4764-9858-c545b86aa46a 61 fields · synced Jul 11, 2026
- EUDAMED 0bbeaa08-66f7-4193-99c0-d17030b8582d 61 fields · synced Sep 17, 2026