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Lower limb brace
EUDAMEDClass I (EU MDR)
Ref Adjustable Ankle-Foot Fixation Orthosis Type VIII （Size S, 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 S, Left） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970604480161 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
Category: Ankle/foot orthosis
Lower limb brace by Xingtai Huaqi Medical Equipment Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 8ddf9f18-1afc-47d8-8fc3-cdd08a7bfc08-1 61 fields · synced Oct 9, 2026