Identity
- Device Name
- Biochip Scanner EUDAMEDBiochip Scanner EUDAMED
- Model / Reference
- L1699 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975760470049 EUDAMED
- Basic UDI-DI
- B-06975760470049 EUDAMED697576047CRS3RL EUDAMED
- EMDN Code
- L1699 DIAGNOSTIC INSTRUMENTS, REUSABLE- OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass A EUDAMED
- Market of Registration
- Romania 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
Yes
EUDAMED
Biochip Scanner by Suzhou Precigenome Ltd, Co; — Class IVD General — IVDR, IVDD — 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/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06975760470049 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06975760470049 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Suzhou Precigenome Ltd, Co;
- EUDAMED SRN
- CN-MF-000024105
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 052c10d7-4c9b-4216-b9ee-977834fb3d00 61 fields · synced Jul 20, 2026
- EUDAMED 76dd8807-77aa-4c1c-aaf5-6f2774d8ec0e 61 fields · synced May 19, 2026