# Kfbio > Active: European Union. Medical device record on deviCERTS, compiled from public registries. - Canonical page: - Manufacturer: [Ningbo Konfoong Bioinformation Tech Co., Ltd.](https://devicerts.com/manufacturers/ningbo-konfoong-bioinformation-tech-co-ltd) (China) - Name in the registry: KFBIO - Device class: Class A (EU IVDR / EU MDR); Class I (EU IVDR / EU MDR) - EMDN: W0599 IVD GENERAL USE CONSUMABLE DEVICES - OTHER - EMDN: W02069099 VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER - EMDN: V92 MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES ## Registrations and authorizations - **EUDAMED** · CE/IVDR · European Union · Basic UDI-DI 697533071KFSLBF22SNA · registered 2025-07-18 · status: Active - **EUDAMED** · CE/MDR · European Union · Basic UDI-DI 697533071KFSLBF22SNA · registered 2025-07-18 · status: Active ## Recalls No recall on record. ## Identity - Device name: Buffer Solution [EUDAMED]; Digital Pathology Slide Scanner [EUDAMED]; Alcohol Solution [EUDAMED]; Digital Slide Scanner [EUDAMED]; Stainer and Coverslipper [EUDAMED]; Pathological Image File Remote Consultation System [EUDAMED]; Segregate Reagent [EUDAMED]; Digital Pathology Slide Management System [EUDAMED]; Papanicolaou EA50 [EUDAMED]; Liquid-based Cytology Processor [EUDAMED]; Rotary Microtome [EUDAMED]; Hematoxylin Staining Solution [EUDAMED]; Specimen Imaging System [EUDAMED] - Model / reference: KF-SLBF-22S [EUDAMED]; 1008 [EUDAMED]; KF-FL-005 [EUDAMED]; 0292 [EUDAMED]; KF-FL-020 [EUDAMED]; 0308 [EUDAMED]; KF-WHBF-23L [EUDAMED]; 1022 [EUDAMED]; KF-PRO-120 [EUDAMED]; 0384 [EUDAMED]; KF-RF-V(CL) [EUDAMED]; 2166 [EUDAMED]; KF-TPP [EUDAMED]; 0346 [EUDAMED]; KF-SPMD-21L [EUDAMED]; 1060 [EUDAMED]; KF-PRO-040 [EUDAMED]; 0377 [EUDAMED]; KF-DSMS [EUDAMED]; 2104 [EUDAMED]; KF-PRX-L [EUDAMED]; 0254 [EUDAMED]; KF-EASL-25L [EUDAMED]; 1015 [EUDAMED]; KF-FL-120 [EUDAMED]; 0322 [EUDAMED]; KF-RF-II [EUDAMED]; 2128 [EUDAMED]; KF-CT-048E [EUDAMED]; 2241 [EUDAMED]; KF-PRO-005 [EUDAMED]; 0353 [EUDAMED]; KF-SLP-200 [EUDAMED]; 2302 [EUDAMED]; KF-PRX-M [EUDAMED]; 0261 [EUDAMED]; KF-PRX-S [EUDAMED]; 0278 [EUDAMED]; KF-HTSL-24L [EUDAMED]; 1039 [EUDAMED]; KF-PRO-400 [EUDAMED]; 0391 [EUDAMED]; KF-GSC-200 [EUDAMED] ## Identifiers - Primary DI / UDI-DI: 06975330711008 [EUDAMED]; 06975330710292 [EUDAMED]; 06975330710308 [EUDAMED]; 06975330711022 [EUDAMED]; 06975330710384 [EUDAMED]; 06975330712166 [EUDAMED]; 06975330710346 [EUDAMED]; 06975330711060 [EUDAMED]; 06975330710377 [EUDAMED]; 06975330712104 [EUDAMED]; 06975330710254 [EUDAMED]; 06975330711015 [EUDAMED]; 06975330710322 [EUDAMED]; 06975330712128 [EUDAMED]; 06975330712241 [EUDAMED]; 06975330710353 [EUDAMED]; 06975330712302 [EUDAMED]; 06975330710261 [EUDAMED]; 06975330710278 [EUDAMED]; 06975330711039 [EUDAMED]; 06975330710391 [EUDAMED] - Basic UDI-DI: 697533071KFSLBF22SNA [EUDAMED]; 697533071FL005BM [EUDAMED]; 697533071FL020BH [EUDAMED]; 697533071KFWHBF23LNF [EUDAMED]; 697533071KFPRO1208E [EUDAMED]; 697533071KFRFV(CL)N5 [EUDAMED]; 697533071KFTPPN2 [EUDAMED]; 697533071KFSPMD21LSQ [EUDAMED]; 697533071KFPRO0408F [EUDAMED]; 697533071KFDSMSMT [EUDAMED]; 697533071PRXLQW [EUDAMED]; 697533071KFEASL25LHD [EUDAMED]; 697533071FL120BN [EUDAMED]; 697533071KFRFIIMU [EUDAMED]; 697533071KFCT048EXF [EUDAMED]; 697533071KFPRO0058D [EUDAMED]; 697533071KFSLP2007R [EUDAMED]; 697533071PRXMQY [EUDAMED]; 697533071PRXSRC [EUDAMED]; 697533071KFHTSL24LSL [EUDAMED]; 697533071KFPRO4008P [EUDAMED]; 697533071KFGSC2002F [EUDAMED] - Direct marketing DI: 06975330710292 [EUDAMED]; 06975330710308 [EUDAMED]; 06975330710384 [EUDAMED]; 06975330710346 [EUDAMED]; 06975330710377 [EUDAMED]; 06975330710322 [EUDAMED]; 06975330710353 [EUDAMED]; 06975330710261 [EUDAMED]; 06975330710278 [EUDAMED]; 06975330710391 [EUDAMED] - EMDN code: W0599 [EUDAMED]; W02069099 [EUDAMED]; V92 [EUDAMED] ## Classification - Device class: Class A [EUDAMED]; Class I [EUDAMED] - Special device type: Software [EUDAMED] - System or procedure pack: System which is a device in itself [EUDAMED] - EU registration type: Standard device [EUDAMED] - EU market of registration: Germany [EUDAMED] ## Properties - Reagent: Yes [EUDAMED]; No [EUDAMED] - IVD instrument: No [EUDAMED]; Yes [EUDAMED] - Supplied sterile: No [EUDAMED] - Sterilise before use: No [EUDAMED] - Implantable: No [EUDAMED] - Reusable: No [EUDAMED] - Contains latex: No [EUDAMED] - Reprocessed single-use device: No [EUDAMED] - Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No [EUDAMED] - Incorporates a substance derived from human blood or plasma: No [EUDAMED] - Contains human tissues or cells: No [EUDAMED] - Contains animal tissues or cells: No [EUDAMED] - Contains substances of microbial origin: No [EUDAMED] - Contains endocrine-disrupting substances: No [EUDAMED] - IVD kit: No [EUDAMED] - Self-testing: No [EUDAMED] - Near-patient testing: No [EUDAMED] - Professional testing: No [EUDAMED] - Companion diagnostics: No [EUDAMED] - Administering medicine: No [EUDAMED] - Measuring function: No [EUDAMED] - New device: No [EUDAMED] - Incorporates a medicinal substance: No [EUDAMED] ## Source and citation - Cite as: Kfbio, Ningbo Konfoong Bioinformation Tech Co., Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/kfbio-1008 (data as of 2026-11-15). - Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed) - Registry records last synced: 2026-10-24 - Statuses computed as of: 2026-11-15 - JSON: - Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms. - Attribution: DevicErts, https://devicerts.com/devices/kfbio-1008 - Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.