← Back to catalogue

Homocysteine Reagent Kit（enzymatic Cycling Method）

EUDAMED

Class IVD General (EU MDR)

Ref 3012554Model R1: 1x60mL, R2: 1x17mLRef 3001697Ref 3000905Model Calibration sample: 2×0.5mLRef 3005503Model R1: 1x60mL, R2: 1x17mL, Control: 1x0.5mLRef 3019740Model R1: 1x60mL, R2: 1x17mL， Calibration sample: 2x0.5mL, Control: 1x0.5mLRef 3021603Ref 3021179Ref 3021715Ref 3021550Ref 3021529Model R1: 1x60mL, R2: 1x17mL, Control: 1x0.5mLRef 3023542Ref 3019748Ref 3019745Model R1: 1x60mL, R2: 1x17mL， Calibration sample: 2x0.5mLRef 3021604

by Dirui Industrial Co., Ltd

Identity

Trade Name
HOMOCYSTEINE REAGENT KIT（ENZYMATIC CYCLING METHOD） EUDAMED
Device Name
HOMOCYSTEINE REAGENT KIT（ENZYMATIC CYCLING METHOD） EUDAMED
Model / Reference
R1: 1x60mL, R2: 1x17mL EUDAMED
3012554 EUDAMED
3001697 EUDAMED
Calibration sample: 2×0.5mL EUDAMED
3000905 EUDAMED
R1: 1x60mL, R2: 1x17mL, Control: 1x0.5mL EUDAMED
3005503 EUDAMED
R1: 1x60mL, R2: 1x17mL， Calibration sample: 2x0.5mL, Control: 1x0.5mL EUDAMED
3019740 EUDAMED
3021603 EUDAMED
3021179 EUDAMED
3021715 EUDAMED
3021550 EUDAMED
R1: 1x60mL, R2: 1x17mL, Control: 1x0.5mL EUDAMED
3021529 EUDAMED
3023542 EUDAMED
3019748 EUDAMED
R1: 1x60mL, R2: 1x17mL， Calibration sample: 2x0.5mL EUDAMED
3019745 EUDAMED
3021604 EUDAMED

Identifiers

Primary DI / UDI-DI
06942202260834 EUDAMED
06942202247057 EUDAMED
06942202261732 EUDAMED
06942202247064 EUDAMED
06942202260872 EUDAMED
06925794593399 EUDAMED
06942202260827 EUDAMED
06925794593382 EUDAMED
06925794593405 EUDAMED
06925794593429 EUDAMED
06942202215957 EUDAMED
06942202260865 EUDAMED
06942202260858 EUDAMED
06925794593412 EUDAMED
Basic UDI-DI
B-06942202260834 EUDAMED
B-06942202247057 EUDAMED
B-06942202261732 EUDAMED
B-06942202247064 EUDAMED
B-06942202260872 EUDAMED
B-06925794593399 EUDAMED
B-06942202260827 EUDAMED
B-06925794593382 EUDAMED
B-06925794593405 EUDAMED
B-06925794593429 EUDAMED
B-06942202215957 EUDAMED
B-06942202260865 EUDAMED
B-06942202260858 EUDAMED
B-06925794593412 EUDAMED
EMDN Code
W01010299 SUBSTRATES - OTHER 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

EUDAMEDEUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

Homocysteine Reagent Kit（enzymatic Cycling 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

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 (14)

  • EUDAMED aa3f375a-ef4c-40b0-95c3-20278502fe60 61 fields · synced Aug 2, 2026
  • EUDAMED 32311bdc-9be5-4756-b67f-5ce4880bd93a 61 fields · synced May 18, 2026
  • EUDAMED 5a25938c-2fc4-4a54-9a6d-b6553c3c6033 61 fields · synced May 18, 2026
  • EUDAMED 010db53e-6a1d-4b12-bfe4-41a8b707f780 61 fields · synced May 19, 2026
  • EUDAMED 3d3328d2-d00d-4bbf-8eae-fb1559f70ae2 61 fields · synced Jun 20, 2026
  • EUDAMED d64c656d-fe56-4a71-bb3e-71e98f776e6c 61 fields · synced Jul 10, 2026
  • EUDAMED a925ec5a-de55-454e-a1cb-37baa155af93 61 fields · synced Jul 14, 2026
  • EUDAMED 1a522009-30c8-49a9-ab71-ec2e24a70e23 61 fields · synced Jul 14, 2026
  • EUDAMED 86e21cbb-c85f-4e94-b215-4731cc28f246 61 fields · synced Jul 15, 2026
  • EUDAMED d3266a36-630f-48df-9a3f-28f073e7ad5f 61 fields · synced Jul 19, 2026
  • EUDAMED e3f7137c-2d27-49e4-8086-1610be87f307 61 fields · synced Jul 23, 2026
  • EUDAMED cb5786e3-4e1b-49b4-97d8-d56cfde3a304 61 fields · synced Jul 24, 2026
  • EUDAMED 628069f9-8c88-44d6-bfac-d00ef625c7ae 61 fields · synced Aug 1, 2026
  • EUDAMED 63a56343-1202-4585-a84c-9dcb73f44122 61 fields · synced Aug 2, 2026