Automatic Biological Reader
by Nantong Ineuthink Medical Technology Co., Ltd 4 variants
Ref BI-10Model BI-3 BI-8 BI-10 BI-12
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697856351ABR01L8 06978563510370 | Date13 May 2025 | 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- Withdrawn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/MDR Active
Specification
- Device Name
- Automatic Biological Reader
- Model / Reference
- BI-3 BI-8 BI-10 BI-12, BI-10
- Primary DI / UDI-DI
- 06978563510370
- Basic UDI-DI
- 697856351ABR01L8
- EMDN Code
- V9099 Various devices not included in other classes - other
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000047513
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Nantong Ineuthink Medical Technology Co., Ltd
See all devices from Nantong Ineuthink Medical Technology Co., Ltd →
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No