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Lower limb brace
EUDAMEDClass I (EU MDR)
Ref Adjustable Ankle-Foot Fixation Orthosis Type III, Short Version（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) Ref Adjustable Ankle-Foot Fixation Orthosis Type VIII （Size S, Right）Ref Adjustable Ankle-Foot Fixation Orthosis Type VI(Size L)Ref Adjustable Ankle-Foot Fixation Orthosis Type Ⅸ, Short Version(Size M)Ref Adjustable Ankle-Foot Fixation Orthosis Type V, Long Version(Size L)Ref Adjustable Ankle-Foot Fixation Orthosis Type V, Short Version(Size S )Ref Adjustable Ankle-Foot Fixation Orthosis Type V, Short Version(Size L)Ref Adjustable Ankle-Foot Fixation Orthosis Type III, Long Version(Size L；Right)Ref OA Knee Joint Orthosis(Riight)Ref Adjustable Ankle-Foot Fixation Orthosis Type Ⅸ, Long Version(Size S )Ref Adjustable Ankle-Foot Fixation Orthosis Type VIII （Size L；Right）Ref Adjustable Ankle-Foot Fixation Orthosis Type V, Long Version(Size S)Ref Adjustable Ankle-Foot Fixation Orthosis Type III, Short Version（Size L；Left）Ref Adjustable Knee-Ankle-Foot Fixation Orthosis(Right1)Ref Adjustable Ankle-Foot Fixation Orthosis Type VI(Size S)Ref Adjustable Ankle-Foot Fixation Orthosis Type V, Long Version(Size M)Ref Adjustable Ankle-Foot Fixation Orthosis Type Ⅸ, Short Version(Size S)Ref Adjustable Ankle-Foot Fixation Orthosis Type VIII （Size XL；Right）Ref Adjustable Ankle-Foot Fixation Orthosis Type V, Short Version(Size M)Ref Adjustable Ankle-Foot Fixation Orthosis Type VIII （Size M；Right）Ref Adjustable Ankle-Foot Fixation Orthosis Type Ⅸ, Short Version(Size L)Ref Adjustable Ankle-Foot Fixation Orthosis Type III, Long Version(Size M；Right)Ref Adjustable Ankle-Foot Fixation Orthosis Type VIII （Size XL；Left）Ref Adjustable Ankle-Foot Fixation Orthosis Type III, Short Version（Size M；Right）Ref Adjustable Ankle-Foot Fixation Orthosis Type Ⅸ, Long Version(Size M)Ref Adjustable Knee Joint Orthosis Type II (One Size Fits All)Ref Upgraded Version of Adjustable Knee Joint Orthosis (One Size Fits All)Ref Adjustable Ankle-Foot Fixation Orthosis Type V, Short Version(Size XL)Ref Adjustable Ankle-Foot Fixation Orthosis Type Ⅸ, Long Version(Size L)
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 III, Short Version（Size S, Left） EUDAMEDAdjustable Ankle-Foot Fixation Orthosis Type VIII （Size S, Right） EUDAMEDAdjustable Ankle-Foot Fixation Orthosis Type VI(Size L) EUDAMEDAdjustable Ankle-Foot Fixation Orthosis Type Ⅸ, Short Version(Size M) EUDAMEDAdjustable Ankle-Foot Fixation Orthosis Type V, Long Version(Size L) EUDAMEDAdjustable Ankle-Foot Fixation Orthosis Type V, Short Version(Size S ) EUDAMEDAdjustable Ankle-Foot Fixation Orthosis Type V, Short Version(Size L) EUDAMEDAdjustable Ankle-Foot Fixation Orthosis Type III, Long Version(Size L；Right) EUDAMEDOA Knee Joint Orthosis(Riight) EUDAMEDAdjustable Ankle-Foot Fixation Orthosis Type Ⅸ, Long Version(Size S ) EUDAMEDAdjustable Ankle-Foot Fixation Orthosis Type VIII （Size L；Right） EUDAMEDAdjustable Ankle-Foot Fixation Orthosis Type V, Long Version(Size S) EUDAMEDAdjustable Ankle-Foot Fixation Orthosis Type III, Short Version（Size L；Left） EUDAMEDAdjustable Knee-Ankle-Foot Fixation Orthosis(Right1) EUDAMEDAdjustable Ankle-Foot Fixation Orthosis Type VI(Size S) EUDAMEDAdjustable Ankle-Foot Fixation Orthosis Type V, Long Version(Size M) EUDAMEDAdjustable Ankle-Foot Fixation Orthosis Type Ⅸ, Short Version(Size S) EUDAMEDAdjustable Ankle-Foot Fixation Orthosis Type VIII （Size XL；Right） EUDAMEDAdjustable Ankle-Foot Fixation Orthosis Type V, Short Version(Size M) EUDAMEDAdjustable Ankle-Foot Fixation Orthosis Type VIII （Size M；Right） EUDAMEDAdjustable Ankle-Foot Fixation Orthosis Type Ⅸ, Short Version(Size L) EUDAMEDAdjustable Ankle-Foot Fixation Orthosis Type III, Long Version(Size M；Right) EUDAMEDAdjustable Ankle-Foot Fixation Orthosis Type VIII （Size XL；Left） EUDAMEDAdjustable Ankle-Foot Fixation Orthosis Type III, Short Version（Size M；Right） EUDAMEDAdjustable Ankle-Foot Fixation Orthosis Type Ⅸ, Long Version(Size M) EUDAMEDAdjustable Knee Joint Orthosis Type II (One Size Fits All) EUDAMEDUpgraded Version of Adjustable Knee Joint Orthosis (One Size Fits All) EUDAMEDAdjustable Ankle-Foot Fixation Orthosis Type V, Short Version(Size XL) EUDAMEDAdjustable Ankle-Foot Fixation Orthosis Type Ⅸ, Long Version(Size L) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970604480000 EUDAMED06970604480178 EUDAMED06970604480154 EUDAMED06970604480352 EUDAMED06970604480260 EUDAMED06970604480277 EUDAMED06970604480291 EUDAMED06970604480093 EUDAMED06970604480437 EUDAMED06970604480314 EUDAMED06970604480215 EUDAMED06970604480246 EUDAMED06970604480048 EUDAMED06970604480451 EUDAMED06970604480130 EUDAMED06970604480253 EUDAMED06970604480345 EUDAMED06970604480239 EUDAMED06970604480284 EUDAMED06970604480192 EUDAMED06970604480369 EUDAMED06970604480079 EUDAMED06970604480222 EUDAMED06970604480031 EUDAMED06970604480321 EUDAMED06970604480383 EUDAMED06970604480406 EUDAMED06970604480307 EUDAMED06970604480338 EUDAMED
- Basic UDI-DI
- 697060448XTHQ00128 EUDAMED
- EMDN Code
- Y061280 LOWER LIMB ORTHOSES - ACCESSORIES EUDAMEDY06120601 PASSIVE ANKLE-FOOT ORTHOSES EUDAMEDY061209 KNEE ORTHOSES EUDAMEDY06121201 PASSIVE KNEE-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 (30)
- EUDAMED 334ff22d-e543-44ae-851c-8b86ee3671c8 61 fields · synced Oct 7, 2026
- EUDAMED 334ff22d-e543-44ae-851c-8b86ee3671c8-1 61 fields · synced Jun 10, 2026
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- EUDAMED 9d8e5477-a009-4677-b0fd-980f9d515eaa-1 61 fields · synced Jul 10, 2026
- EUDAMED 7f5254c9-2e0a-4df6-8c78-59c8e7359e79-1 61 fields · synced Jul 10, 2026
- EUDAMED 0ed148d8-30ee-42e3-a70c-31301016bce3-1 61 fields · synced Jul 11, 2026
- EUDAMED 2d98bba0-7494-4672-8d8e-1f5f2311bedf 61 fields · synced Jul 11, 2026
- EUDAMED 227124c4-3bb6-4a28-89f3-27c2c4f3945f-1 61 fields · synced Jul 11, 2026
- EUDAMED 66150ae4-cecd-45b1-ac4e-559147186f21 61 fields · synced Jul 11, 2026
- EUDAMED 727b1ddd-4ea1-48ef-b061-94190377575b-1 61 fields · synced Jul 13, 2026
- EUDAMED 203cfc35-372e-41a8-8c40-91b9560ffd49-1 61 fields · synced Jul 15, 2026
- EUDAMED c9797a71-7010-4183-8666-49837981cd2c 61 fields · synced Jul 16, 2026
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- EUDAMED b19dc3fd-6ea7-4627-b72e-90c15a6f52f9-1 61 fields · synced Jul 24, 2026
- EUDAMED 92043667-c191-4e20-8d6d-1abdc3df495a 61 fields · synced Jul 25, 2026
- EUDAMED 941816a4-c793-4ff3-81be-f195f14da21c-1 61 fields · synced Jul 29, 2026
- EUDAMED 5bd4eb8c-18f4-441d-93a9-468f349449c4-1 61 fields · synced Jul 29, 2026
- EUDAMED d5cac085-c4be-4fc4-95cb-e08f00b1dbdb 61 fields · synced Jul 30, 2026
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- EUDAMED d824a04f-5d3b-4cf1-877d-3dd9df27b98e-1 61 fields · synced Aug 2, 2026
- EUDAMED fa7cc3e2-6b35-4896-a3fd-ed0cd3a2fe81 61 fields · synced Aug 3, 2026
- EUDAMED a39f6c2e-3b23-40c5-b826-62eb72a206e0 61 fields · synced Aug 4, 2026
- EUDAMED 83a838cf-a2d6-444a-b7e8-fb455925d29b-1 61 fields · synced Sep 18, 2026
- EUDAMED 80415017-6a0e-42d5-a5a5-1f24ccb6bc86-1 61 fields · synced Sep 18, 2026