TherMidas Remote
by TherMidas Oy Finland EUDAMEDGUDID
Ref ThRemote
Product code LHQEMDN Z119013
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | NumberD-ThRemoteCA | Date3 Aug 2023 | StatusIn distribution |
| European Union | CE/MDD EUDAMED | NumberB-ThRemoteCA | Date21 Dec 2021 | StatusActive |
Coverage
- Expiring (legacy directive)
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- TherMidas Remote EUDAMEDThermidas GUDID
- Generic Name
- Infrared thermography system
- Device Name
- TherMidas Remote Version 1.3
- Model / Ref / Catalog
- ThRemote, Thermidas Remote SW
- Primary DI / UDI-DI
- D-ThRemoteCA EUDAMED06429810718013 GUDID
- Basic UDI-DI
- B-ThRemoteCA
- 510(k) Number
- FDA Product Code
- LHQ
- EMDN Code
- Z119013 Thermographs
- GMDN Term
- Infrared thermography system
- Device Class
- Class I
- Regulation Number
- 884.2980
- Market of Registration
- Finland
- Commercial Distribution
- In Commercial Distribution
- MRI Safety
- MR Unsafe
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | ThRemote | Thermidas Remote SW |
| Primary DI / UDI-DI | D-ThRemoteCA | 06429810718013 |
Manufacturer details
- EUDAMED SRN
- FI-MF-000007644
Other devices from TherMidas Oy
Properties & raw data
Show properties, registry sources and raw records
Other properties (19)
- Sterile: No
- Single Use: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Expiration Date: No
- Manufacturing Date: No
Sources (2)
- EUDAMED e7f423d5-f92e-4159-beac-262c8c7905f5
- FDA UDI 1ba658f0-2dfd-4064-8da2-9ae3acae862a