Medical Temperature Control Instrument
by Tongda Medical Equipment (Zibo) Co., Ltd.
Ref 02001Model TMS-Sen, TMS-Std, TMS-Str, TMS-Pro, TMS-Max, TMS-Ultra, TMS-Por
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number698018974020013C 06980189740048 | Date12 Oct 2026 | 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- Withdrawn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
- Device Name
- Medical Temperature Control Instrument
- Model / Reference
- TMS-Sen, TMS-Std, TMS-Str, TMS-Pro, TMS-Max, TMS-Ultra, TMS-Por, 02001
- Primary DI / UDI-DI
- 06980189740048
- Basic UDI-DI
- 698018974020013C
- Direct Marketing DI
- 06980189740048
- EMDN Code
- Z1208040301 Fixed neonatal incubators
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000058404
- Authorised representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Other devices from Tongda Medical Equipment (Zibo) Co., Ltd.
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