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Automatic Digital Slice Scanning Processing System
EUDAMEDClass A (EU MDR)
Ref IBL300Model IBL500
Identity
- Device Name
- Automatic Digital Slice Scanning Processing System EUDAMED
- Model / Reference
- IBL500 EUDAMEDIBL300 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948500932893 EUDAMED
- Basic UDI-DI
- 69485009IBL001KH EUDAMED
- Direct Marketing DI
- 06948500932893 EUDAMED
- EMDN Code
- W0299 IVD INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A 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
Automatic Digital Slice Scanning Processing System by Guangzhou LBP Medicine Science & Technology Co., Ltd. — Class A — IVDR — listed in EUDAMED
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 | 69485009IBL001KH | Class A | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000026786
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED fbad5cf4-1784-429f-8d2d-516c24eafc4f 61 fields · synced Oct 6, 2026