Apo B
by Aidian Oy
Ref 67249
Apo B (67249) is a device classified as IVD General made by Aidian Oy, registered in EUDAMED on 3 Aug 2022 (Basic UDI-DI B-06438115000471), active as of 22 Oct 2026.
Active
CE IVDD
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-06438115000471 06438115000471 | Date3 Aug 2022 | StatusActive |
Official records
- EUDAMED public site B-06438115000471
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD Active
Specification
- Model / reference
- 67249
- Primary DI / UDI-DI
- 06438115000471
- Basic UDI-DI
- B-06438115000471
- EMDN code
- W0102010403 Apolipoprotein b
- Device class
- Class IVD General
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- Finland
Manufacturer details
- EUDAMED SRN
- FI-MF-000023611
Similar devices in this category
Other devices filed under APOLIPOPROTEIN B.
- Lipoprotein (a) (Lpa) Assay Kit (Immunoturbidimetric Method) R1：15ml×1，R2：5ml×1 by E-LAB Biological Science & Technology Co., Ltd.
- BIOBASE R1:18mL×4 R2:6mL×4 R1:18mL×4 R2:6mL×4 by Biobase Biodustry(Shandong) Co.,Ltd.
- Mercodia Oxidized LDL ELISA 10-1143-01 by Mercodia AB
- BIOBASE R1:60mL×2 R2:20mL×2 R1:60mL×2 R2:20mL×2 by Biobase Biodustry(Shandong) Co.,Ltd.
- Atellica CH APO B 11097626 by Siemens Healthcare Diagnostics Inc.
- N Antiserum to Human Apolipoprotein B 10446286 OSAN09 by SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- APO B OSR6143 by Beckman Coulter, Inc.
- Apolipoprotein B 981930 by Thermo Fisher Scientific Oy
- Apolipoprotein B (APO-B) Assay Kit (Immunoturbidimetric Method) 96H160TSC by YHLO BIOTECH (NANJING) CO., LTD.
- Diazyme DZ142A-K by Diazyme Laboratories, Inc.