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Glycohemoglobin A 1c Reagent Kit
EUDAMEDClass IVD General (EU MDR)
Ref 3021159Model R1:2×15mL,R2:R2-A:1×0.5mL R2-B:1×9.5mL ,Lyse:2×50mL, Diluent:7mL,Calibration sample: 5x1mL,
Identity
- Trade Name
- GLYCOHEMOGLOBIN A 1C REAGENT KIT EUDAMED
- Device Name
- GLYCOHEMOGLOBIN A 1C REAGENT KIT EUDAMED
- Model / Reference
- R1:2×15mL,R2:R2-A:1×0.5mL R2-B:1×9.5mL ,Lyse:2×50mL, Diluent:7mL,Calibration sample: 5x1mL, EUDAMED3021159 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202259982 EUDAMED
- Basic UDI-DI
- B-06942202259982 EUDAMED
- EMDN Code
- W01010214 GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
Glycohemoglobin A 1c Reagent Kit 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-06942202259982 | 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 21836b41-d2a4-4190-abff-8f6608e054af 61 fields · synced Jun 18, 2026