Kfbio
by Ningbo Konfoong Bioinformation Tech Co., Ltd. 15 variants
Ref 0315Model KF-FL-040
Kfbio (0315) is an in vitro diagnostic device (EU IVDR Class A; EMDN category various sample processing instruments) made by Ningbo Konfoong Bioinformation Tech Co., Ltd., registered in EUDAMED on 5 Dec 2025 (Basic UDI-DI 697533071FL040BP), active as of 24 Oct 2026.
Active
CE IVDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697533071FL040BP 06975330710315 | Date5 Dec 2025 | StatusActive |
Official records
- EUDAMED public site 697533071FL040BP
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- Withdrawn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/IVDR Active
Specification
- Device name
- Digital Pathology Slide Scanner
- Model / reference
- KF-FL-040, 0315
- Primary DI / UDI-DI
- 06975330710315
- Basic UDI-DI
- 697533071FL040BP
- Direct marketing DI
- 06975330710315
- EMDN code
- W02069099 Various sample processing instruments - other
- Device class
- Class A
- Special device type
- Software
- EU registration type
- Standard device
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000030466
- Authorised representative
- Share info GmbH DE-AR-000005132
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