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Eclipse Silicone Suspension Sleeve (Tan)

by Regal Prosthesis Limited 3 variants

Ref 3-01-ECSS-L-TN

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number48952003003RP6V Basic UDI-DI 04895200310952UDI-DIDate29 Jun 2026RegisteredStatusActive

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  • Withdrawn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
Prosthetic Suspension Systems
Model / Reference
3-01-ECSS-L-TN
Primary DI / UDI-DI
04895200310952
Basic UDI-DI
48952003003RP6V
EMDN Code
Y062409 Transtibial prostheses (for amputation under knee)
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
HK-MF-000028642
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Regal Prosthesis Limited

See all devices from Regal Prosthesis Limited →

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