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SACH Foot

by e-life International Co., Ltd. 41 variants

Ref EL-PFT9028-RY3000BModel PFT90, PFT91, PFT92

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number471989492SACHFOOTJG Basic UDI-DI 04719961409116UDI-DIDate25 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  • Withdrawn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
SACH Foot
Model / Reference
PFT90, PFT91, PFT92, EL-PFT9028-RY3000B
Primary DI / UDI-DI
04719961409116
Basic UDI-DI
471989492SACHFOOTJG
EMDN Code
Y062499 Lower extremity 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