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Automatic Digital Slice Scanning System
EUDAMEDClass A (EU MDR)
Ref FL-200Model IBL 200Model IBL 200, IBL 400, IBL 700, IBL 006F, IBL 030F, IBL 060F, IBL 240F, IBL 480F, BL-006, BL-020, BL-040, BL-060, BL-200, BL-300, BL-400, BL-600, FL-006, FL-020, FL-040, FL-060, FL-200, FL-300, FL-400, FL-600
Identity
- Device Name
- Automatic Digital Slice Scanning System EUDAMEDDigital Slide Scanner for Pathology EUDAMED
- Model / Reference
- IBL 200 EUDAMEDFL-200 EUDAMEDIBL 200, IBL 400, IBL 700, IBL 006F, IBL 030F, IBL 060F, IBL 240F, IBL 480F, BL-006, BL-020, BL-040, BL-060, BL-200, BL-300, BL-400, BL-600, FL-006, FL-020, FL-040, FL-060, FL-200, FL-300, FL-400, FL-600 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975767420245 EUDAMED
- Basic UDI-DI
- 697576742SliceScanning2U EUDAMED697576742IBL0001RR EUDAMED
- Direct Marketing DI
- 06975767420245 EUDAMED
- EMDN Code
- W02069099 VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER EUDAMEDW0202059099 VARIOUS PROCESSING INSTRUMENTS FOR HYSTOLOGY / CYTOLOGY - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
The Automatic Digital Slice Scanning System is a cutting-edge medical device designed for precise and accurate diagnostic imaging. Utilizing advanced digital slice scanning technology, this innovative device provides high-quality images of the human body, enabling healthcare professionals to diagnose and treat various conditions with unprecedented accuracy.
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 | 697576742SliceScanning2U | Class A | Active |
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Manufacturer
- Manufacturer
- Suzhou Betrue Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000039348
- Authorised Representative
- R Sight B.V. NL-AR-000010445
Sources (2)
- EUDAMED 3839e993-c298-4732-8929-c6cd4c69d5cb 61 fields · synced Jul 10, 2026
- EUDAMED fe26b36b-55dd-4b58-bbea-a87472ac5d45 61 fields · synced Jul 10, 2026