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Lower limb brace

EUDAMED

Class I (EU MDR)

Ref Adjustable Ankle-Foot Fixation Orthosis Type III, Long Version(Size L；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)

by Xingtai Huaqi Medical Equipment Co., Ltd

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) EUDAMED
Adjustable Ankle-Foot Fixation Orthosis Type III, Long Version(Size L；Left) EUDAMED

Identifiers

Primary DI / UDI-DI
06970604480086 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

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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 11dfd06b-9006-447d-b10f-821c4df9b843-1 61 fields · synced Oct 7, 2026