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Digital Slide Scanner for Pathology
EUDAMEDClass A (EU MDR)
Ref IBL FP20Model 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
- Digital Slide Scanner for Pathology EUDAMED
- Model / Reference
- 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 EUDAMEDIBL FP20 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975767420061 EUDAMED
- Basic UDI-DI
- 697576742IBL0001RR EUDAMED
- EMDN Code
- W0202059099 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
Digital Slide Scanner for Pathology by Suzhou Betrue Technology 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 | 697576742IBL0001RR | Class A | Active |
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Manufacturer
- Manufacturer
- Suzhou Betrue Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000039348
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (1)
- EUDAMED c69e3802-a882-4b30-b290-3b8eaa236e2e 61 fields · synced Jul 26, 2026