← Back to catalogue
Apolipoprotein B (ApoB)
EUDAMEDClass IVD General (EU MDR)
Ref ECH0109158Ref ECH0103158Ref ECH0504158Ref ECH0502158Ref ECH0101158
Identity
- Device Name
- Apolipoprotein B (ApoB) EUDAMED
- Model / Reference
- ECH0109158 EUDAMEDECH0103158 EUDAMEDECH0504158 EUDAMEDECH0502158 EUDAMEDECH0101158 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-ECH01091586X EUDAMEDD-ECH01031585M EUDAMEDD-ECH05041587G EUDAMEDD-ECH050215872 EUDAMEDD-ECH010115857 EUDAMED
- Basic UDI-DI
- B-ECH01091586X EUDAMEDB-ECH01031585M EUDAMEDB-ECH05041587G EUDAMEDB-ECH050215872 EUDAMEDB-ECH010115857 EUDAMED
- EMDN Code
- W0102010403 APOLIPOPROTEIN B 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
Apolipoprotein B (ApoB) by Maccura Biotechnology Co., Ltd. — 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-ECH01091586X | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Maccura Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000014618
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (5)
- EUDAMED 3b276d9b-4c16-44b1-91ec-f1199326471e 61 fields · synced Aug 4, 2026
- EUDAMED 4e9b8351-3838-4123-bc11-1e8457007016 61 fields · synced May 16, 2026
- EUDAMED 6e14d5d1-6123-476f-8763-8b43da297a3c 61 fields · synced May 17, 2026
- EUDAMED 7f1bfa5a-c18d-423b-a19d-628a63f61fe5 61 fields · synced May 18, 2026
- EUDAMED fcbddc73-4a4a-469a-8f8b-c2b37838c019 61 fields · synced May 18, 2026