Kfbio
by Ningbo Konfoong Bioinformation Tech Co., Ltd. 15 variants
Ref 1008, 0292, 0308, 1022, 0384, 2166, 0346, 1060, 0377, 2104, 0254, 1015, 0322, 2128, 2241, 0353, 2302, 0261, 0278, 1039, 0391Model KF-SLBF-22S, KF-FL-005, KF-FL-020, KF-WHBF-23L, KF-PRO-120, KF-RF-V(CL), KF-TPP, KF-SPMD-21L, KF-PRO-040, KF-DSMS, KF-PRX-L, KF-EASL-25L, KF-FL-120, KF-RF-II, KF-CT-048E, KF-PRO-005, KF-SLP-200, KF-PRX-M, KF-PRX-S, KF-HTSL-24L, KF-PRO-400, KF-GSC-200
Kfbio (1008) is an in vitro diagnostic device (EU IVDR Class A; EU IVDR Class I) made by Ningbo Konfoong Bioinformation Tech Co., Ltd., registered in EUDAMED on 18 Jul 2025 (Basic UDI-DI 697533071KFSLBF22SNA), active as of 24 Oct 2026.
Active
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 | Number697533071KFSLBF22SNA | Date18 Jul 2025 | StatusActive |
| European Union | CE/MDR | Number697533071KFSLBF22SNA | Date18 Jul 2025 | StatusActive |
Official records
- EUDAMED public site 697533071KFSLBF22SNA
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- Withdrawn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, CE/MDR Active
Specification
- Device name
- Buffer SolutionDigital Pathology Slide ScannerAlcohol SolutionDigital Slide ScannerStainer and CoverslipperPathological Image File Remote Consultation SystemSegregate ReagentDigital Pathology Slide Management SystemPapanicolaou EA50Liquid-based Cytology ProcessorRotary MicrotomeHematoxylin Staining SolutionSpecimen Imaging System
- Model / reference
- KF-SLBF-22S, 1008, KF-FL-005, 0292, KF-FL-020, 0308, KF-WHBF-23L, 1022, KF-PRO-120, 0384, KF-RF-V(CL), 2166, KF-TPP, 0346, KF-SPMD-21L, 1060, KF-PRO-040, 0377, KF-DSMS, 2104, KF-PRX-L, 0254, KF-EASL-25L, 1015, KF-FL-120, 0322, KF-RF-II, 2128, KF-CT-048E, 2241, KF-PRO-005, 0353, KF-SLP-200, 2302, KF-PRX-M, 0261, KF-PRX-S, 0278, KF-HTSL-24L, 1039, KF-PRO-400, 0391, KF-GSC-200
- Primary DI / UDI-DI
- 06975330711008, 06975330710292, 06975330710308, 06975330711022, 06975330710384, 06975330712166, 06975330710346, 06975330711060, 06975330710377, 06975330712104, 06975330710254, 06975330711015, 06975330710322, 06975330712128, 06975330712241, 06975330710353, 06975330712302, 06975330710261, 06975330710278, 06975330711039, 06975330710391
- Basic UDI-DI
- 697533071KFSLBF22SNA, 697533071FL005BM, 697533071FL020BH, 697533071KFWHBF23LNF, 697533071KFPRO1208E, 697533071KFRFV(CL)N5, 697533071KFTPPN2, 697533071KFSPMD21LSQ, 697533071KFPRO0408F, 697533071KFDSMSMT, 697533071PRXLQW, 697533071KFEASL25LHD, 697533071FL120BN, 697533071KFRFIIMU, 697533071KFCT048EXF, 697533071KFPRO0058D, 697533071KFSLP2007R, 697533071PRXMQY, 697533071PRXSRC, 697533071KFHTSL24LSL, 697533071KFPRO4008P, 697533071KFGSC2002F
- Direct marketing DI
- 06975330710292069753307103080697533071038406975330710346069753307103770697533071032206975330710353069753307102610697533071027806975330710391
- EMDN code
- W0599, W02069099, V92
- Device class
- Class AClass I
- Special device type
- Software
- System or procedure pack
- System which is a device in itself
- 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
Similar devices in this category
Other devices filed under VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER.
- Sentinel Sentinel V1 by VistaPath Biosystems, Inc.
- Incubator I002 by CHANGSHA YINGTAI INSTRUMENT CO., LTD
- Automated Nucleic Acid Extraction Workstation SAW-96 by JIANGSU BIOPERFECTUS TECHNOLOGIES CO., LTD.
- Nucleic Acid Extractor 043 by SINGUWAY BIOTECH INC.
- HURO PATH® T ALBCCZ003 by CelltraZone Co., Ltd
- Nucleic Acid Extraction System SSNP-2000B by JIANGSU BIOPERFECTUS TECHNOLOGIES CO., LTD.
- KingFisher™ Apex Dx Purification Instrument by Life Technologies Holdings Pte Ltd.
- Incubator I001 by CHANGSHA YINGTAI INSTRUMENT CO., LTD
- Nucleic Acid Extraction NAE-0132 by Infitek Co., Ltd.
- Automated Workstation for Nucleic Acid Extraction and PCR Test ZJYY-D-20215E by SHANGHAI ZJ BIO-TECH CO., LTD.
Other devices from Ningbo Konfoong Bioinformation Tech Co., Ltd.
See all devices from Ningbo Konfoong Bioinformation Tech Co., Ltd. →