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Cervical Thoracic Orthosis
EUDAMEDClass I (EU MDR)
Ref ZCF-6-11Model Trunk Orthoses
Identity
- Trade Name
- Cervical Thoracic Orthosis EUDAMED
- Model / Reference
- Trunk Orthoses EUDAMEDZCF-6-11 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978867215940 EUDAMED
- Basic UDI-DI
- 697886721TO000TV EUDAMED
- Direct Marketing DI
- 06978867215940 EUDAMED
- EMDN Code
- Y060399 SPINE ORTHOSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Cervical Thoracic Orthosis by Medi Global Assistive Device Co., Ltd. — 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 | 697886721TO000TV | Class I | Active |
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Manufacturer
- Manufacturer
- Medi Global Assistive Device Co., Ltd.
- EUDAMED SRN
- CN-MF-000034804
- Authorised Representative
- Humiss International B.V. NL-AR-000001490
Sources (1)
- EUDAMED b49531ae-8555-45e6-b298-3fb6ed87e5ac 61 fields · synced Jul 9, 2026