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ROM Air Walking Boot

EUDAMED

Class I (EU MDR)

Ref 635202(14M/UNI/Gray&Silver)Model Air Walking Boot:635102 GoFit Walker:635302 Lite Ped.Walking Boot:638801 Power Walking Boot:635301 Pro Ped.Walking Boot:638802 ROM Air Walking Boot:635202 ROM Air Walking Boot Pro:635204 ROM Walking Boot:635201 etc

by Zhangpu Ortholife Rehabilitation Co., Ltd.

Identity

Trade Name
ROM Air Walking Boot EUDAMED
Device Name
Walking Boots (Ankle/foot orthosis) EUDAMED
Model / Reference
Air Walking Boot:635102 GoFit Walker:635302 Lite Ped.Walking Boot:638801 Power Walking Boot:635301 Pro Ped.Walking Boot:638802 ROM Air Walking Boot:635202 ROM Air Walking Boot Pro:635204 ROM Walking Boot:635201 etc EUDAMED
635202(14M/UNI/Gray&Silver) EUDAMED

Identifiers

Primary DI / UDI-DI
04719872865292 EUDAMED
Basic UDI-DI
47198728663WQ EUDAMED
EMDN Code
Y06120601 PASSIVE ANKLE-FOOT ORTHOSES EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Greece 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

ROM Air Walking Boot by Zhangpu Ortholife Rehabilitation 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
Zhangpu Ortholife Rehabilitation Co., Ltd.
EUDAMED SRN
CN-MF-000011447
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (1)

  • EUDAMED eee76486-4f83-4d66-8cda-6252676b8766 61 fields · synced Jun 17, 2026