Identity
- Device Name
- Incubator EUDAMED
- Model / Reference
- LS-10 EUDAMEDF1-10 EUDAMEDLS-30 EUDAMEDF3-30 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971763225174 EUDAMED06971763225167 EUDAMED
- Basic UDI-DI
- 69717632236785001UT EUDAMED69717632236785002UV EUDAMED
- Direct Marketing DI
- 06971763225174 EUDAMED06971763225167 EUDAMED
- EMDN Code
- W0299 IVD INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy 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
Incubator by Lansion Biotechnology 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 | 69717632236785001UT | Class A | Active |
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Manufacturer
- Manufacturer
- Lansion Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000001086
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 75d3399d-e02a-4b2d-981e-bc3840deda95 61 fields · synced Jul 22, 2026
- EUDAMED b0b174ce-3122-4dd6-8f26-51e2c67203b0 61 fields · synced May 17, 2026