← Back to catalogue

Glycohemoglobin A 1c Reagent Kit

EUDAMED

Class IVD General (EU MDR)

Ref 3009802Model R1: 1x60mL, R2: 1x20mL,Diluent: 7mL, Calibration sample: 5×1mLRef 3014906Model R1:2×15ml , R2-A：1×0.5ml, R2-B：1×9.5ml, Lyse：2×50ml, Diluent: 5ml, Control: 2x1mlRef 3009800Model R1: 1x60mL, R2: 1x20mL,Diluent: 7mL, Calibration sample: 5×1mL,Control: 2x1mLRef 3012544Model R1:2×15mL , R2-A：1×0.5mL, R2-B：1×9.5mL, Lyse：2×50mLRef 3009804Model R1: 1x60mL, R2: 1x20mL,Diluent: 7mL, Control: 2x1mLRef 3012188Model R1: 1x60mL, R2: 1x20mLRef 3001058Model R1:15mL×2 , R2-A：0.5mL×1, R2-B：9.5mL×1, Lyse：50mL×2Ref 3014894Model R1:2×15mL , R2-A：1×0.5mL, R2-B：1×9.5mL, Lyse：2×50mL, Diluent: 5mL, Calibration sample: 5x1mLRef 3004701Model R1:2×15mL,R2:R2-A:1×0.5mL R2-B:1×9.5mL,Lyse:2×50mL,Diluent:7mL,Calibration sample: 5x1mL, Ref 3016511Model R1:2×15mL,R2:R2-A:1×0.5mL R2-B:1×9.5mL ,Lyse:2×50mL, Diluent:7mL,1x20mL, Calibration sample: 5x1mL, Control: 2x1mLRef 3023248Model R1:2×15mL,R2:R2-A:1×0.5mL R2-B:1×9.5mL,Lyse:2×50mL,Diluent:7mL,Calibration sample: 5x1mL, Control: 2x1mLRef 3023242Model R1:1×60mL,R2：1×20mL ，Diluent: 7mL,Calibration sample: 5x1mL, Control: 2x1mLRef 3004702Model R1:2×15mL,R2:R2-A:1×0.5mL R2-B:1×9.5mL,Lyse:2×50mL,Diluent:7mL, Control: 2x1mLRef 3021571Ref 3023075Model Control: 2×1mL, Diluent: 7mL

by Dirui Industrial Co., Ltd

Identity

Trade Name
GLYCOHEMOGLOBIN A 1C REAGENT KIT EUDAMED
Device Name
GLYCOHEMOGLOBIN A 1C REAGENT KIT EUDAMED
Model / Reference
R1: 1x60mL, R2: 1x20mL,Diluent: 7mL, Calibration sample: 5×1mL EUDAMED
3009802 EUDAMED
R1:2×15ml , R2-A：1×0.5ml, R2-B：1×9.5ml, Lyse：2×50ml, Diluent: 5ml, Control: 2x1ml EUDAMED
3014906 EUDAMED
R1: 1x60mL, R2: 1x20mL,Diluent: 7mL, Calibration sample: 5×1mL,Control: 2x1mL EUDAMED
3009800 EUDAMED
R1:2×15mL , R2-A：1×0.5mL, R2-B：1×9.5mL, Lyse：2×50mL EUDAMED
3012544 EUDAMED
R1: 1x60mL, R2: 1x20mL,Diluent: 7mL, Control: 2x1mL EUDAMED
3009804 EUDAMED
R1: 1x60mL, R2: 1x20mL EUDAMED
3012188 EUDAMED
R1:15mL×2 , R2-A：0.5mL×1, R2-B：9.5mL×1, Lyse：50mL×2 EUDAMED
3001058 EUDAMED
R1:2×15mL , R2-A：1×0.5mL, R2-B：1×9.5mL, Lyse：2×50mL, Diluent: 5mL, Calibration sample: 5x1mL EUDAMED
3014894 EUDAMED
R1:2×15mL,R2:R2-A:1×0.5mL R2-B:1×9.5mL,Lyse:2×50mL,Diluent:7mL,Calibration sample: 5x1mL, EUDAMED
3004701 EUDAMED
R1:2×15mL,R2:R2-A:1×0.5mL R2-B:1×9.5mL ,Lyse:2×50mL, Diluent:7mL,1x20mL, Calibration sample: 5x1mL, Control: 2x1mL EUDAMED
3016511 EUDAMED
R1:2×15mL,R2:R2-A:1×0.5mL R2-B:1×9.5mL,Lyse:2×50mL,Diluent:7mL,Calibration sample: 5x1mL, Control: 2x1mL EUDAMED
3023248 EUDAMED
R1:1×60mL,R2：1×20mL ，Diluent: 7mL,Calibration sample: 5x1mL, Control: 2x1mL EUDAMED
3023242 EUDAMED
R1:2×15mL,R2:R2-A:1×0.5mL R2-B:1×9.5mL,Lyse:2×50mL,Diluent:7mL, Control: 2x1mL EUDAMED
3004702 EUDAMED
3021571 EUDAMED
Control: 2×1mL, Diluent: 7mL EUDAMED
3023075 EUDAMED

Identifiers

Primary DI / UDI-DI
06942202246739 EUDAMED
06942202239946 EUDAMED
06942202246722 EUDAMED
06942202260025 EUDAMED
06942202246746 EUDAMED
06942202246753 EUDAMED
06942202240966 EUDAMED
06942202260018 EUDAMED
06942202212161 EUDAMED
06942202259975 EUDAMED
06942202213519 EUDAMED
06942202213106 EUDAMED
06942202246715 EUDAMED
06925794593283 EUDAMED
06942202261633 EUDAMED
Basic UDI-DI
B-06942202246739 EUDAMED
B-06942202239946 EUDAMED
B-06942202246722 EUDAMED
B-06942202260025 EUDAMED
B-06942202246746 EUDAMED
B-06942202246753 EUDAMED
B-06942202240966 EUDAMED
B-06942202260018 EUDAMED
B-06942202212161 EUDAMED
B-06942202259975 EUDAMED
B-06942202213519 EUDAMED
B-06942202213106 EUDAMED
B-06942202246715 EUDAMED
B-06925794593283 EUDAMED
B-06942202261633 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Dirui Industrial Co., Ltd
EUDAMED SRN
CN-MF-000001891
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (15)

  • EUDAMED 5384a83e-b834-41b0-8718-dc3bca316c3a 61 fields · synced Aug 3, 2026
  • EUDAMED e67c1293-6a01-43d9-8c36-4cc581debc36 61 fields · synced May 16, 2026
  • EUDAMED c131e1c8-055b-4e30-8adf-0d0dab30a583 61 fields · synced May 17, 2026
  • EUDAMED c6b6d775-3d90-434d-afe1-f492ab4ab847 61 fields · synced May 18, 2026
  • EUDAMED b0202e43-fabd-41e0-81e0-0c525449b7c2 61 fields · synced May 18, 2026
  • EUDAMED 6b7e4508-f2d9-4865-bc1e-1cc3b9560c69 61 fields · synced May 18, 2026
  • EUDAMED 1fcd8794-13d0-4fa5-9931-0d2562d9b223 61 fields · synced May 18, 2026
  • EUDAMED f6fbb10d-ad83-4e49-8ac7-d2722b5a196d 61 fields · synced May 19, 2026
  • EUDAMED 562c7680-98a6-4b42-bfb1-3bb332f3190c 61 fields · synced Jul 11, 2026
  • EUDAMED b880d4bd-7c44-462a-9f72-ef6324c33dde 61 fields · synced Jul 16, 2026
  • EUDAMED cb7ab62e-8183-41af-ad18-6ee203ef34f7 61 fields · synced Jul 22, 2026
  • EUDAMED 84a55c54-ab8a-437d-9320-4b84381d5c52 61 fields · synced Jul 24, 2026
  • EUDAMED 98de92dc-f90f-426e-9314-9864e2daab5d 61 fields · synced Jul 24, 2026
  • EUDAMED b4cef71e-607a-44d9-902d-32f332cbbf34 61 fields · synced Aug 3, 2026
  • EUDAMED 4df490a6-1321-4c3c-ac4d-0ec47f36a841 61 fields · synced Aug 3, 2026