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Glucose Reagent Kit(glucose Oxidase Method)
EUDAMEDClass IVD General (EU MDR)
Ref 3002389Model R1: 5x50mL, R2: 1x50mL, Calibration sample: 2mLRef 3000604Model R1: 4x50mL, R2: 2x25mL, Calibration sample: 2mLRef 3021158Model R1: 4x50mL, R2: 1x50mL，Calibration sample: 2mLRef 3023243Ref 3016549
Identity
- Trade Name
- GLUCOSE REAGENT KIT(GLUCOSE OXIDASE METHOD) EUDAMED
- Device Name
- GLUCOSE REAGENT KIT(GLUCOSE OXIDASE METHOD) EUDAMED
- Model / Reference
- R1: 5x50mL, R2: 1x50mL, Calibration sample: 2mL EUDAMED3002389 EUDAMEDR1: 4x50mL, R2: 2x25mL, Calibration sample: 2mL EUDAMED3000604 EUDAMEDR1: 4x50mL, R2: 1x50mL，Calibration sample: 2mL EUDAMED3021158 EUDAMED3023243 EUDAMED3016549 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202246692 EUDAMED06942202257421 EUDAMED06942202259944 EUDAMED06942202213137 EUDAMED06942202259968 EUDAMED
- Basic UDI-DI
- B-06942202246692 EUDAMEDB-06942202257421 EUDAMEDB-06942202259944 EUDAMEDB-06942202213137 EUDAMEDB-06942202259968 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(glucose Oxidase 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-06942202246692 | 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 ab3a02af-7ac3-47b5-8e3c-f174b778d5fa 61 fields · synced Aug 2, 2026
- EUDAMED 4f07593f-04b9-444d-91a4-ae6c62fd84e7 61 fields · synced May 19, 2026
- EUDAMED f66cebad-4179-4bb9-a84f-081d1c795265 61 fields · synced Jun 18, 2026
- EUDAMED 7e5b4999-3490-4e4a-a96b-28907df3cac8 61 fields · synced Jul 31, 2026
- EUDAMED fa418f28-c395-48f8-9ad3-22a9456aed31 61 fields · synced Aug 2, 2026