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Temperature Management System
EUDAMEDClass IIb (EU MDR)
Ref TC-150Model TC-200,TC-150,TC-100Ref TC-100
Identity
- Trade Name
- Temperature Management System EUDAMED
- Device Name
- Temperature Management System EUDAMED
- Model / Reference
- TC-200,TC-150,TC-100 EUDAMEDTC-150 EUDAMEDTC-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975984062341 EUDAMED06975984062358 EUDAMED
- Basic UDI-DI
- 6970341680111201GL EUDAMED
- Direct Marketing DI
- 06975984062341 EUDAMED06975984062358 EUDAMED
- EMDN Code
- Z12040208 BODY THERMOREGULATION EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Temperature Management System by Shenzhen Lifotronic Technology Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6970341680111201GL | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shenzhen Lifotronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005654
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 95604a4f-3504-462d-a489-e10e52f4b7a8 61 fields · synced Jul 16, 2026
- EUDAMED 148d9d77-4f11-424b-b5ae-fd476157b8dc 61 fields · synced May 18, 2026