T-Balance Plus lämpöasu L/XL
Ref 161-L/XL
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Overview
T-Balance Plus lämpöasu L/XL is a cutting-edge, FDA-cleared device designed for accurate and reliable temperature measurement in medical settings. This innovative device offers precise temperature readings, making it an essential tool for healthcare professionals to ensure patient safety and optimize treatment outcomes.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number64298301198161UR 06429830119845 | Date15 Dec 2021 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- 161-L/XL
- Primary DI / UDI-DI
- 06429830119845
- Basic UDI-DI
- 64298301198161UR
- Direct Marketing DI
- 06429830119845
- EMDN Code
- T0299 Protection drapes and garments - other
- Device Class
- Class I
- EU market of registration
- Finland
Manufacturer details
- EUDAMED SRN
- FI-MF-000011731
Other devices from Telespro Finland Oy
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No