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Foot Lift

EUDAMED

Class I (EU MDR)

Ref 620006(M/UNI/Gray&Silver)Model AFO Splint 620001 AFO Leaf Spring 620002 Dorsal Night Splint:620016 Night Splint:620003 Soft Night Splint:620004

by Zhangpu Ortholife Rehabilitation Co., Ltd.

Identity

Trade Name
Foot Lift EUDAMED
Device Name
Ankle Brace, Ankle Foot Orthosis, Night Splint (Ankle/foot orthosis) EUDAMED
Model / Reference
AFO Splint 620001 AFO Leaf Spring 620002 Dorsal Night Splint:620016 Night Splint:620003 Soft Night Splint:620004 EUDAMED
620006(M/UNI/Gray&Silver) EUDAMED

Identifiers

Primary DI / UDI-DI
04719872865803 EUDAMED
Basic UDI-DI
47198728662WN EUDAMED
EMDN Code
Y06120601 PASSIVE ANKLE-FOOT ORTHOSES EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Ireland 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

Foot Lift by Zhangpu Ortholife Rehabilitation Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Ankle/foot orthosis.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
CN-MF-000011447
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (1)

  • EUDAMED 8638932d-404e-4f26-96c8-cc7ab8f5f3f2 61 fields · synced Jun 19, 2026