← Back to catalogue
Lipoprotein (a) (Lp(a)) Kit(Immunoturbidimetric Method)
EUDAMEDClass IVD General (EU MDR)
Ref 01.09.02.09.EC.01
by Zybio Inc.
Identity
- Device Name
- Lipoprotein (a) (Lp(a)) Kit(Immunoturbidimetric Method) EUDAMED
- Model / Reference
- 01.09.02.09.EC.01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941967204848 EUDAMED
- Basic UDI-DI
- B-06941967204848 EUDAMED
- EMDN Code
- W0102010405 LIPOPROTEIN ( A ) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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
Category: Apolipoprotein B (Apo B) IVD, reagent
Lipoprotein (a) (Lp(a)) Kit(Immunoturbidimetric Method) by Zybio Inc. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Apolipoprotein B (Apo B) IVD, reagent.
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
- Lipoprotein (a) — Diagam S.A. · IVD General
- Adenosine Deaminase Assay Kit (Peroxidase Method) — Da Te Bioengineering Technology Co., LTD. · IVD General
- Apolipoprotein B Reagent (ApoB 2 x 100) — Beckman Coulter, Inc. · IVD General
- Apolipoprotein B Assay Kit (Immunoturbidimetric Method) — Da Te Bioengineering Technology Co., LTD. · IVD General
- Lipoprotein (a) Kit (Latex-Enhanced Immunoturbidimetric Method) — MEDICALSYSTEM BIOTECHNOLOGY CO., LTD. · IVD General
- Apolipoprotein B Assay Kit (Immunoturbidimetric Method) — Da Te Bioengineering Technology Co., LTD. · IVD General
- Adenosine Deaminase Assay Kit (Peroxidase Method) — Da Te Bioengineering Technology Co., LTD. · IVD General
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-06941967204848 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zybio Inc.
- EUDAMED SRN
- CN-MF-000003349
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 3498d016-57d6-4bd8-81dc-1a8f10308c99 61 fields · synced Jul 11, 2026