BCB Neonatal intensive care Register
Ref 06430078510523
Active
CE MDR
Valid until
11 Feb 2031
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberFI23/0000002 | Date29 Jul 2026 | StatusActive |
Certificates
- FI23/0000002 Active
Quality management system EU MDR
- Certifier
- SGS FIMKO OY 0598
- Issued
- 29 Jul 2026
- Expires
- 11 Feb 2031
- Valid from
- 14 Aug 2026
- Reason
- Mnf data change
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Disease Specific Register
- Model / Reference
- 06430078510523
- Primary DI / UDI-DI
- 06430078510523
- Basic UDI-DI
- 643007851BCBDSR2H
- EMDN Code
- V92 Medical device software - not included in other classes
- Device Class
- Class IIa
- EU market of registration
- Finland
Manufacturer details
- EUDAMED SRN
- FI-MF-000002441
Other devices from BCB Medical Oy
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