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Homocysteine (HCY) Test Kit (Enzymatic)
EUDAMEDClass IVD General (EU MDR)
Ref R1:40mL×2 R2:13mL×2(701)Ref R1:40mL×2 R2:13mL×2(715)Ref R1:20mL×1 R2:6.5mL×1（702）Ref R1:48mL×1 R2:13mL×1（700081）Ref R1:40mL×2 R2:13mL×2(792)Ref R1:40mL×2 R2:13mL×2(706)Ref R1:20mL×4 R2:6.5mL×4（710）Ref R1:20mL×4 R2:6.5mL×4（707）Ref R1:20mL×2 R2:13mL×1（704）Ref 质控品：1mL×1（92141）Ref 校准品：1mL×2（91128）Ref R1:40mL×1 R2a:7mL×1 R2b:6mL×1（701）Model R1:40mL×1 R2a:7mL×1 R2b:6mL×1(701)
Identity
- Trade Name
- Homocysteine (HCY) Test Kit (Enzymatic) EUDAMED
- Device Name
- Homocysteine (HCY) Test Kit (Enzymatic) EUDAMED
- Model / Reference
- R1:40mL×2 R2:13mL×2(701) EUDAMEDR1:40mL×2 R2:13mL×2(715) EUDAMEDR1:20mL×1 R2:6.5mL×1（702） EUDAMEDR1:48mL×1 R2:13mL×1（700081） EUDAMEDR1:40mL×2 R2:13mL×2(792) EUDAMEDR1:40mL×2 R2:13mL×2(706) EUDAMEDR1:20mL×4 R2:6.5mL×4（710） EUDAMEDR1:20mL×4 R2:6.5mL×4（707） EUDAMEDR1:20mL×2 R2:13mL×1（704） EUDAMED质控品：1mL×1（92141） EUDAMED校准品：1mL×2（91128） EUDAMEDR1:40mL×1 R2a:7mL×1 R2b:6mL×1(701) EUDAMEDR1:40mL×1 R2a:7mL×1 R2b:6mL×1（701） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971674868590 EUDAMED06971674868729 EUDAMED06971674868613 EUDAMED06936895300427 EUDAMED06971674868682 EUDAMED06971674868644 EUDAMED06971674868705 EUDAMED06971674868651 EUDAMED06971674868620 EUDAMED06971674868309 EUDAMED06971674867951 EUDAMED06971674866657 EUDAMED
- Basic UDI-DI
- B-06971674868590 EUDAMEDB-06971674868729 EUDAMEDB-06971674868613 EUDAMEDB-06936895300427 EUDAMEDB-06971674868682 EUDAMEDB-06971674868644 EUDAMEDB-06971674868705 EUDAMEDB-06971674868651 EUDAMEDB-06971674868620 EUDAMEDB-06971674868309 EUDAMEDB-06971674867951 EUDAMEDB-06971674866657 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-06971674868590 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biobase Biodustry(Shandong) Co., Ltd.
- EUDAMED SRN
- CN-MF-000025015
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (12)
- EUDAMED 07b66b26-96a8-44ed-b006-4420f6ddd04d 61 fields · synced Oct 6, 2026
- EUDAMED c938dcf1-8852-49d7-938a-3e96e0a1543c 61 fields · synced May 16, 2026
- EUDAMED d0c96e6b-ffb3-41dc-9f16-90064efa6fab 61 fields · synced May 16, 2026
- EUDAMED 1de81a19-f1f9-4cde-aec2-6cb3b3c64b6a 61 fields · synced May 17, 2026
- EUDAMED a2d4aa2b-2d56-4914-8820-d8049705d372 61 fields · synced May 18, 2026
- EUDAMED 81af6583-1980-4e7c-a599-18e11633313b 61 fields · synced May 18, 2026
- EUDAMED 0d03b3df-0601-4d05-bdfc-a549768e71f3 61 fields · synced May 19, 2026
- EUDAMED b308abc1-0e15-4972-bc66-ca9d688525b3 61 fields · synced May 19, 2026
- EUDAMED 37633455-9280-4447-9479-a025c73b8067 61 fields · synced May 19, 2026
- EUDAMED f2745387-bfb3-41e9-9a38-17642e0c76e1 61 fields · synced Jul 10, 2026
- EUDAMED 3d2cdbba-784a-43a7-8cfe-7899f63b694a 61 fields · synced Jul 11, 2026
- EUDAMED d14285e1-cfaf-4fc9-96fc-3bc50cdb460d 61 fields · synced Jul 12, 2026