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Foot Shell

by e-life International Co., Ltd. 14 variants

Ref EL-PFS0124-LB0000B, EL-PFS0126-RY0000B, EL-PFS0127-RY0000B, EL-PFS0123-LY0000B, EL-PFS0125-LY0000B, EL-PFS0123-RB0000B, EL-PFS0124-RB0000B, EL-PFS0127-LB0000B, EL-PFS0126-LB0000B, EL-PFS0126-LY0000B, EL-PFS0122-RY0000BModel PFS01

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number471989492FOOTSHELLEK Basic UDI-DI Date25 Apr 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Foot Shell
Model / Reference
PFS01, EL-PFS0124-LB0000B, EL-PFS0126-RY0000B, EL-PFS0127-RY0000B, EL-PFS0123-LY0000B, EL-PFS0125-LY0000B, EL-PFS0123-RB0000B, EL-PFS0124-RB0000B, EL-PFS0127-LB0000B, EL-PFS0126-LB0000B, EL-PFS0126-LY0000B, EL-PFS0122-RY0000B
Primary DI / UDI-DI
04719961407235, 04719961407341, 04719961407389, 04719961407204, 04719961407280, 04719961407211, 04719961407259, 04719961407358, 04719961407310, 04719961407327, 04719961407181
Basic UDI-DI
471989492FOOTSHELLEK
EMDN Code
Y090399 Clothes, footwear and covers for prostheses - other
Device Class
Class I
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
TW-MF-000043583
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from e-life International Co., Ltd.

See all devices from e-life International Co., Ltd. →

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No