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Glycohemoglobin A 1c Reagent Kit
EUDAMEDClass IVD General (EU MDR)
Ref 3004623Model R1:2×15ml,R2-A:1×0.5ml,R2-B:1×9.5ml, Lyse：2×50mL, Diluent: 7mL, Calibration sample: 5×1mL, Control: 2×1mL,Ref 3019915Model 500mL
Identity
- Trade Name
- GLYCOHEMOGLOBIN A 1C REAGENT KIT EUDAMEDLyse EUDAMED
- Device Name
- GLYCOHEMOGLOBIN A 1C REAGENT KIT EUDAMEDLyse EUDAMED
- Model / Reference
- R1:2×15ml,R2-A:1×0.5ml,R2-B:1×9.5ml, Lyse：2×50mL, Diluent: 7mL, Calibration sample: 5×1mL, Control: 2×1mL, EUDAMED3004623 EUDAMED500mL EUDAMED3019915 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202240973 EUDAMED06925794577986 EUDAMED
- Basic UDI-DI
- B-06942202240973 EUDAMED69422022W010301010513R07S EUDAMED
- EMDN Code
- W01010214 GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC) EUDAMEDW0103010105 CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEATH-FLUIDS) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass A EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMEDEUDAMED
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
New Device
No
EUDAMED
Glycohemoglobin A 1c Reagent Kit by Dirui Industrial Co., Ltd — Class IVD General — IVDR, IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06942202240973 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06942202240973 | 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 (2)
- EUDAMED ff44ef72-0fb5-47fe-abf5-d2fae99ef79b 61 fields · synced Sep 18, 2026
- EUDAMED 13ef3c71-cf05-41f0-aa86-d5504c5abcb1 61 fields · synced Jul 9, 2026