On Call
by Acon Biotech (Hangzhou) Co., Ltd. 8 variants
Ref G126-172Model OGC-221
Active
CE IVDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-G126-172J6 D-G126-172J6 | Date19 Jun 2026 | StatusActive |
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- Withdrawn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
- Device Name
- On Call MultiPro HbA1c Controls
- Model / Reference
- OGC-221, G126-172
- Primary DI / UDI-DI
- D-G126-172J6
- Basic UDI-DI
- B-G126-172J6
- EMDN Code
- W0102160801 Controls immunochem - rt & poc
- Device Class
- Class IVD General
- EU market of registration
- Romania
Manufacturer details
- EUDAMED SRN
- CN-MF-000006977
- Authorised representative
- MedNet EC-REP GmbH DE-AR-000000002
Other devices from Acon Biotech (Hangzhou) Co., Ltd.
Properties
Other properties (8)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No