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Carbon AAFO

by Zhangpu Ortholife Rehabilitation Co., Ltd. EUDAMED

Active European Union

Ref 626303(XL/Left/Black)Model AFO Splint 620001 AFO Leaf Spring 620002 Dorsal Night Splint:620016 Night Splint:620003 Soft Night Splint:620004

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number47198728662WN Basic UDI-DIDate15 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Ankle Brace, Ankle Foot Orthosis, Night Splint (Ankle/foot orthosis)
Model / Reference
AFO Splint 620001 AFO Leaf Spring 620002 Dorsal Night Splint:620016 Night Splint:620003 Soft Night Splint:620004, 626303(XL/Left/Black)
Primary DI / UDI-DI
04719964469674
Market of Registration
Netherlands

Manufacturer details

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

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