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Kfbio
EUDAMEDClass A (EU MDR)
Ref 1008Model KF-SLBF-22SRef 0292Model KF-FL-005Ref 0308Model KF-FL-020Ref 1022Model KF-WHBF-23LRef 0384Model KF-PRO-120Ref 2166Model KF-RF-V(CL)Ref 0346Model KF-TPPRef 1060Model KF-SPMD-21LRef 0377Model KF-PRO-040Ref 2104Model KF-DSMSRef 0254Model KF-PRX-LRef 1015Model KF-EASL-25LRef 0322Model KF-FL-120Ref 2128Model KF-RF-IIRef 2241Model KF-CT-048ERef 0353Model KF-PRO-005Ref 2302Model KF-SLP-200Ref 0261Model KF-PRX-MRef 0278Model KF-PRX-SRef 1039Model KF-HTSL-24LRef 0391Model KF-PRO-400
Identity
- Trade Name
- KFBIO EUDAMED
- Device Name
- Buffer Solution EUDAMEDDigital Pathology Slide Scanner EUDAMEDAlcohol Solution EUDAMEDDigital Slide Scanner EUDAMEDStainer and Coverslipper EUDAMEDPathological Image File Remote Consultation System EUDAMEDSegregate Reagent EUDAMEDDigital Pathology Slide Management System EUDAMEDPapanicolaou EA50 EUDAMEDLiquid-based Cytology Processor EUDAMEDRotary Microtome EUDAMEDHematoxylin Staining Solution EUDAMED
- Model / Reference
- KF-SLBF-22S EUDAMED1008 EUDAMEDKF-FL-005 EUDAMED0292 EUDAMEDKF-FL-020 EUDAMED0308 EUDAMEDKF-WHBF-23L EUDAMED1022 EUDAMEDKF-PRO-120 EUDAMED0384 EUDAMEDKF-RF-V(CL) EUDAMED2166 EUDAMEDKF-TPP EUDAMED0346 EUDAMEDKF-SPMD-21L EUDAMED1060 EUDAMEDKF-PRO-040 EUDAMED0377 EUDAMEDKF-DSMS EUDAMED2104 EUDAMEDKF-PRX-L EUDAMED0254 EUDAMEDKF-EASL-25L EUDAMED1015 EUDAMEDKF-FL-120 EUDAMED0322 EUDAMEDKF-RF-II EUDAMED2128 EUDAMEDKF-CT-048E EUDAMED2241 EUDAMEDKF-PRO-005 EUDAMED0353 EUDAMEDKF-SLP-200 EUDAMED2302 EUDAMEDKF-PRX-M EUDAMED0261 EUDAMEDKF-PRX-S EUDAMED0278 EUDAMEDKF-HTSL-24L EUDAMED1039 EUDAMEDKF-PRO-400 EUDAMED0391 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975330711008 EUDAMED06975330710292 EUDAMED06975330710308 EUDAMED06975330711022 EUDAMED06975330710384 EUDAMED06975330712166 EUDAMED06975330710346 EUDAMED06975330711060 EUDAMED06975330710377 EUDAMED06975330712104 EUDAMED06975330710254 EUDAMED06975330711015 EUDAMED06975330710322 EUDAMED06975330712128 EUDAMED06975330712241 EUDAMED06975330710353 EUDAMED06975330712302 EUDAMED06975330710261 EUDAMED06975330710278 EUDAMED06975330711039 EUDAMED06975330710391 EUDAMED
- Basic UDI-DI
- 697533071KFSLBF22SNA EUDAMED697533071FL005BM EUDAMED697533071FL020BH EUDAMED697533071KFWHBF23LNF EUDAMED697533071KFPRO1208E EUDAMED697533071KFRFV(CL)N5 EUDAMED697533071KFTPPN2 EUDAMED697533071KFSPMD21LSQ EUDAMED697533071KFPRO0408F EUDAMED697533071KFDSMSMT EUDAMED697533071PRXLQW EUDAMED697533071KFEASL25LHD EUDAMED697533071FL120BN EUDAMED697533071KFRFIIMU EUDAMED697533071KFCT048EXF EUDAMED697533071KFPRO0058D EUDAMED697533071KFSLP2007R EUDAMED697533071PRXMQY EUDAMED697533071PRXSRC EUDAMED697533071KFHTSL24LSL EUDAMED697533071KFPRO4008P EUDAMED
- Direct Marketing DI
- 06975330710292 EUDAMED06975330710308 EUDAMED06975330710384 EUDAMED06975330710346 EUDAMED06975330710377 EUDAMED06975330710322 EUDAMED06975330710353 EUDAMED06975330710261 EUDAMED06975330710278 EUDAMED06975330710391 EUDAMED
- EMDN Code
- W0599 IVD GENERAL USE CONSUMABLE DEVICES - OTHER EUDAMEDW02069099 VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER EUDAMEDV92 MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class A EUDAMEDClass I EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Reagent
Yes
EUDAMEDEUDAMED
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
Surgical Instrument
No
EUDAMEDEUDAMED
New Device
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Kfbio by Ningbo Konfoong Bioinformation Tech Co., Ltd. — Class A — IVDR, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697533071KFSLBF22SNA | Class A | Active |
| EUDAMED | European Union | CE/MDR | 697533071KFSLBF22SNA | Class A | Active |
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Manufacturer
- Manufacturer
- Ningbo Konfoong Bioinformation Tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000030466
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (21)
- EUDAMED 025c4bc6-3725-4779-b574-4d0432cfee25 61 fields · synced Sep 17, 2026
- EUDAMED b8ba8cc0-c386-4fc7-9189-29c2029cc35e 61 fields · synced May 16, 2026
- EUDAMED 1c3aa76d-d43c-4563-a2de-2dd90b5de0b3 61 fields · synced May 16, 2026
- EUDAMED c51ce3de-1296-448d-9b64-4c7bf2971ab9 61 fields · synced May 16, 2026
- EUDAMED c7cd3250-b540-4afc-b5c5-f9fede17bffc 61 fields · synced May 16, 2026
- EUDAMED a4308872-7cd5-4c26-a2c5-8f4d46e8182e 61 fields · synced May 16, 2026
- EUDAMED 1cb6cd50-d1a3-47f9-8e63-9d7c09637064 61 fields · synced May 17, 2026
- EUDAMED 438b4c56-e3b5-4c26-9e4b-033498bf77dc 61 fields · synced May 17, 2026
- EUDAMED 413a8b7f-fa79-432a-af03-c0127d019ace 61 fields · synced May 17, 2026
- EUDAMED a2279ace-bc3a-4c71-ac70-f631fedb12ce 61 fields · synced May 17, 2026
- EUDAMED ac83234e-018b-4b67-9448-471511dccc94 61 fields · synced May 17, 2026
- EUDAMED fd52aa7c-ce53-408d-a47e-9087bc4c93b6 61 fields · synced May 17, 2026
- EUDAMED f52ec026-eee5-4a2c-9a7c-a60b752411a8 61 fields · synced May 18, 2026
- EUDAMED 82038162-472b-4953-b8ce-f259b57a0d8d 61 fields · synced May 18, 2026
- EUDAMED ab15872c-c4a0-4857-b9a2-4554b2a755ef 61 fields · synced May 18, 2026
- EUDAMED 45144a02-ee56-489c-a669-74629ad71cd8 61 fields · synced May 18, 2026
- EUDAMED a59f9636-7685-4c2f-856d-03868e590ae5 61 fields · synced May 18, 2026
- EUDAMED 0c552f5d-b404-47cc-8260-a612a3896219 61 fields · synced May 18, 2026
- EUDAMED a820d019-4e0b-4cb5-a9d5-e64ccdf0b009 61 fields · synced May 18, 2026
- EUDAMED 68d9fa16-aa02-44a5-aa54-e8b813af920e 61 fields · synced May 18, 2026
- EUDAMED 708f0ebf-10a4-4772-ad8a-5a097c34a9df 61 fields · synced May 18, 2026