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Lower limb brace
EUDAMEDClass I (EU MDR)
Ref Adjustable Ankle-Foot Fixation Orthosis Type VIII （Size M；Left）Model Ankle-Foot Orthosis: Adjustable Ankle-Foot Fixation Orthosis Type III, Short Version (Size S, Left; Size S, Right; Size M, Left; Size M, Right; Size L, Left; Size L, Right)
Identity
- Device Name
- Lower limb brace EUDAMED
- Model / Reference
- Ankle-Foot Orthosis: Adjustable Ankle-Foot Fixation Orthosis Type III, Short Version (Size S, Left; Size S, Right; Size M, Left; Size M, Right; Size L, Left; Size L, Right) EUDAMEDAdjustable Ankle-Foot Fixation Orthosis Type VIII （Size M；Left） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970604480185 EUDAMED
- Basic UDI-DI
- 697060448XTHQ00128 EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Lower limb brace by Xingtai Huaqi Medical Equipment 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 | 697060448XTHQ00128 | Class I | Active |
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Manufacturer
- Manufacturer
- Xingtai Huaqi Medical Equipment Co., Ltd
- EUDAMED SRN
- CN-MF-000047104
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED b6d4d605-0fe4-4ff1-bd1a-b2e40988d94f 61 fields · synced Oct 8, 2026