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Homocysteine (HCY) Reagent Kit (Enzymatic Cycling Method)
EUDAMEDClass IVD General (EU MDR)
Ref 3019755Model R1: 1x60mL, R2: 1x17mLRef 3019756Model R1: 1x60mL, R2: 1x17mL, Calibration sample: 2x0.5mLRef 3019741Model R1: 1x60mL, R2: 1x17mL, Control: 1x0.5mLRef 3019751Model R1: 1x60mL, R2: 1x17mL, Calibration sample: 2x0.5mL, Control: 1x0.5mLRef 3019744
Identity
- Trade Name
- Homocysteine (HCY) Reagent Kit (Enzymatic Cycling Method) EUDAMEDHOMOCYSTEINE REAGENT KIT（ENZYMATIC CYCLING METHOD） EUDAMED
- Device Name
- Homocysteine (HCY) Reagent Kit (Enzymatic Cycling Method) EUDAMEDHOMOCYSTEINE REAGENT KIT（ENZYMATIC CYCLING METHOD） EUDAMED
- Model / Reference
- R1: 1x60mL, R2: 1x17mL EUDAMED3019755 EUDAMEDR1: 1x60mL, R2: 1x17mL, Calibration sample: 2x0.5mL EUDAMED3019756 EUDAMEDR1: 1x60mL, R2: 1x17mL, Control: 1x0.5mL EUDAMED3019741 EUDAMEDR1: 1x60mL, R2: 1x17mL, Calibration sample: 2x0.5mL, Control: 1x0.5mL EUDAMED3019751 EUDAMED3019744 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202244766 EUDAMED06942202244773 EUDAMED06942202244780 EUDAMED06942202244797 EUDAMED06942202260841 EUDAMED
- Basic UDI-DI
- B-06942202244766 EUDAMEDB-06942202244773 EUDAMEDB-06942202244780 EUDAMEDB-06942202244797 EUDAMEDB-06942202260841 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
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
Homocysteine (HCY) Reagent Kit (Enzymatic Cycling 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-06942202244766 | 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 (5)
- EUDAMED cd865d0a-f22c-4948-9247-482245468a5f 61 fields · synced Aug 4, 2026
- EUDAMED 51883864-d1f9-4f30-8545-e6377e82d7ae 61 fields · synced May 17, 2026
- EUDAMED e4786891-cab1-4227-83e1-6d31d9db0658 61 fields · synced May 18, 2026
- EUDAMED df771e69-1881-4342-8a34-ac6ca808ca5c 61 fields · synced May 19, 2026
- EUDAMED 6e31f943-cc16-45bd-9023-f84c256c35db 61 fields · synced Jul 16, 2026