Identity
- Trade Name
- Thornhill Research Inc. EUDAMEDMOVES SLC FDA UDI
- Generic Name
- Portable electric ventilator FDA UDI
- Device Name
- MOVES® SLC™ Device [MOVES SLC System] EUDAMEDASSY, MOVES SLC System in Case FDA UDI
- Model / Reference
- 124846 EUDAMEDFDA UDI
- Description
- ASSY, MOVES SLC System in Case FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10807141000114 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10807141000114 EUDAMED
- 510(k) Number
- K161420 FDA UDI
- FDA Product Code
- BTL FDA UDICAW FDA UDIMWI FDA UDIBTA FDA UDI
- EMDN Code
- Z12030104 PORTABLE PULMONARY VENTILATORS EUDAMED
- GMDN Term
- Portable electric ventilator FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5925 FDA UDI868.5440 FDA UDI870.2300 FDA UDI878.4780 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Thornhill Research Inc. by Thornhill Research Inc — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-10807141000114 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Thornhill Research Inc
- EUDAMED SRN
- CA-MF-000039470
- Authorised Representative
- Freyr Regulatory GmbH DE-AR-000047121
Sources (2)
- EUDAMED 91026043-5d1c-4830-883c-83345e6e4f2d 61 fields · synced Aug 4, 2026
- FDA UDI 3d298b3f-2969-4b4b-9385-df4aae1f6916 35 fields · synced May 30, 2026