← Back to catalogue
Homocysteine (HCY) Test Kit (Enzymatic)
EUDAMEDClass IVD General (EU MDR)
Ref R1:40mL×2 R2:13mL×2(705)Model 06971674868637(705)Ref R1:40mL×2 R2:13mL×2(791)
Identity
- Trade Name
- Homocysteine (HCY) Test Kit (Enzymatic) EUDAMED
- Device Name
- Homocysteine (HCY) Test Kit (Enzymatic) EUDAMED
- Model / Reference
- 06971674868637(705) EUDAMEDR1:40mL×2 R2:13mL×2(705) EUDAMEDR1:40mL×2 R2:13mL×2(791) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971674868637 EUDAMED06971674868675 EUDAMED
- Basic UDI-DI
- B-06971674868637 EUDAMEDB-06971674868675 EUDAMED
- EMDN Code
- W01021307 HOMOCYSTEINE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
Homocysteine (HCY) Test Kit (Enzymatic) by Biobase Biodustry(Shandong) 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-06971674868637 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biobase Biodustry(Shandong) Co., Ltd.
- EUDAMED SRN
- CN-MF-000025015
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (2)
- EUDAMED 316ea8bd-1ae5-491e-88a5-430dac64a2fb 61 fields · synced Jun 20, 2026
- EUDAMED 34adb5c6-21da-4540-a156-1b389118f90a 61 fields · synced May 19, 2026