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Fructosamine Reagent Kit ( Nitrotetrazolium-Blue Reduction Method)
EUDAMEDClass IVD General (EU MDR)
Ref 3000854Model R: 4x50mL,Calibration sample: 1mLRef 3016179Model R: 4x50mL,Calibration sample: 1mL, Control: 2x1mLRef 3012496Model R: 5x50mL,Calibration sample: 1x1mLRef 3021186Model R:5x50mL, Calibration sample: 1mL, Control: 2x1mLRef 3021688Model R: 5x50mL, Calibration sample: 1mL, Control: 2x1mLRef 3021717Model R:5x50mL, Calibration sample: 1mLRef 3021150
Identity
- Trade Name
- FRUCTOSAMINE REAGENT KIT ( NITROTETRAZOLIUM-BLUE REDUCTION METHOD) EUDAMED
- Device Name
- FRUCTOSAMINE REAGENT KIT ( NITROTETRAZOLIUM-BLUE REDUCTION METHOD) EUDAMED
- Model / Reference
- R: 4x50mL,Calibration sample: 1mL EUDAMED3000854 EUDAMEDR: 4x50mL,Calibration sample: 1mL, Control: 2x1mL EUDAMED3016179 EUDAMEDR: 5x50mL,Calibration sample: 1x1mL EUDAMED3012496 EUDAMEDR:5x50mL, Calibration sample: 1mL, Control: 2x1mL EUDAMED3021186 EUDAMEDR: 5x50mL, Calibration sample: 1mL, Control: 2x1mL EUDAMED3021688 EUDAMEDR:5x50mL, Calibration sample: 1mL EUDAMED3021717 EUDAMED3021150 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202259845 EUDAMED06942202259852 EUDAMED06942202259883 EUDAMED06942202259876 EUDAMED06925794592538 EUDAMED06925794592545 EUDAMED06942202259869 EUDAMED
- Basic UDI-DI
- B-06942202259845 EUDAMEDB-06942202259852 EUDAMEDB-06942202259883 EUDAMEDB-06942202259876 EUDAMEDB-06925794592538 EUDAMEDB-06925794592545 EUDAMEDB-06942202259869 EUDAMED
- EMDN Code
- W01010210 FRUCTOSAMINE 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
No
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
Fructosamine Reagent Kit ( Nitrotetrazolium-Blue Reduction Method) by Dirui Industrial Co., Ltd — Class IVD General — IVDD — listed in EUDAMED
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-06942202259845 | 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 7150cebb-21c9-46b7-8109-6bbc3e7d0688 61 fields · synced Jul 21, 2026
- EUDAMED f71025b5-d359-4d5a-946f-9a77c5dd2518 61 fields · synced May 18, 2026
- EUDAMED 8eeeee82-ef12-400c-8d38-7ba375182457 61 fields · synced May 18, 2026
- EUDAMED 17e97259-c9b2-4d5f-8617-b67dda2c78b7 61 fields · synced Jun 20, 2026
- EUDAMED e771a357-bdc9-4a77-9e08-aaa5f8e714e1 61 fields · synced Jul 8, 2026
- EUDAMED 6b4f59cc-c2f0-468d-8d0b-ef0d4cfce9c9 61 fields · synced Jul 11, 2026
- EUDAMED 21163c91-ea18-4b6e-bf6f-a2901d7d4572 61 fields · synced Jul 21, 2026