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3/5 Arch Support

EUDAMED

Class I (EU MDR)

Ref 640010(M/UNI/Black)Model “U” Shaped Heel Cushion:640008 3/4 Arch Support:640010 3/5 Arch Support:640010 3/6 Arch Support:640010 3/7 Arch Support:640010 Full Length Cushioning Insole:640009 Full Length Insole:640001 Heel Cup Central Spur:640004 etc

by Zhangpu Ortholife Rehabilitation Co., Ltd.

Identity

Trade Name
3/5 Arch Support EUDAMED
Device Name
Insole (Orthotic insole) EUDAMED
Model / Reference
“U” Shaped Heel Cushion:640008 3/4 Arch Support:640010 3/5 Arch Support:640010 3/6 Arch Support:640010 3/7 Arch Support:640010 Full Length Cushioning Insole:640009 Full Length Insole:640001 Heel Cup Central Spur:640004 etc EUDAMED
640010(M/UNI/Black) EUDAMED

Identifiers

Primary DI / UDI-DI
04719892931625 EUDAMED
Basic UDI-DI
47198728664WS EUDAMED
EMDN Code
Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) 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

3/5 Arch Support 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 d26365ed-b81b-409c-b41e-7e92ec1b57f5 61 fields · synced Oct 6, 2026