Identity
- Device Name
- Therm-X Garment - Back EUDAMED
- Model / Reference
- Z120616 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850001096393 EUDAMED
- Basic UDI-DI
- 08500010960105BD EUDAMED
- Direct Marketing DI
- 00850001096393 EUDAMED
- EMDN Code
- Z120616 ELECTROMECHANICAL SYSTEMS FOR PHYSICAL THERAPY EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Therm-X Garment - Back by Zenith Technical Innovations, LLC. — Class I — 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 | 08500010960105BD | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zenith Technical Innovations, LLC.
- EUDAMED SRN
- US-MF-000047832
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (1)
- EUDAMED 0d606313-2aad-428e-aa27-40441390603c 61 fields · synced Jul 24, 2026