Identity
- Trade Name
- KFBIO EUDAMED
- Device Name
- Digital Pathology Slide Scanner EUDAMED
- Model / Reference
- KF-PRX-XL EUDAMED0285 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975330710285 EUDAMED
- Basic UDI-DI
- 697533071PRXXLTH EUDAMED
- Direct Marketing DI
- 06975330710285 EUDAMED
- EMDN Code
- W02069099 VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Kfbio by Ningbo Konfoong Bioinformation Tech Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697533071PRXXLTH | 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 (1)
- EUDAMED 5e218b2b-2c81-40d8-9a0b-4dcfc6d2a8a7 61 fields · synced Jun 18, 2026