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Full Length Cushioning Insole

EUDAMED

Class I (EU MDR)

Ref 640009(L/XL/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
Full Length Cushioning Insole 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
640009(L/XL/UNI/Black) EUDAMED

Identifiers

Primary DI / UDI-DI
04719892931601 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

Full Length Cushioning Insole 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 ffdae85e-9674-4671-9f1a-0806695ecfca 61 fields · synced Oct 9, 2026