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Cervical Thoracic Brace
EUDAMEDClass I (EU MDR)
Ref ZCF-6-14Model Trunk OrthosesRef GTJ-21
Identity
- Trade Name
- Cervical Thoracic Brace EUDAMEDCervical Thoracic Brace II EUDAMED
- Model / Reference
- Trunk Orthoses EUDAMEDZCF-6-14 EUDAMEDGTJ-21 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978867215957 EUDAMED06978867215964 EUDAMED
- Basic UDI-DI
- 697886721TO000TV EUDAMED
- Direct Marketing DI
- 06978867215957 EUDAMED06978867215964 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 Brace 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 (2)
- EUDAMED fe9e93d2-af22-41a0-82ff-17b377e69a67 61 fields · synced Jul 22, 2026
- EUDAMED 4d008ac3-dc4a-4211-b3a6-6021bbc96ca7 61 fields · synced May 18, 2026