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Hd Sphinkeeper – 10X Self Expandable Implant (S)

by Thd S.P.A.

Ref 820018Model THD SPHINKEEPER – 10X SELF EXPANDABLE IMPLANT (S)

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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number803373771IMPSYS001RK Basic UDI-DI 08051687051115UDI-DIDate9 Sep 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Thd Sphinkeeper – 10X Self Expandable Implant (S)
Model / Reference
THD SPHINKEEPER – 10X SELF EXPANDABLE IMPLANT (S), 820018
Primary DI / UDI-DI
08051687051115
Basic UDI-DI
803373771IMPSYS001RK
EMDN Code
P050499 Faecal incontinence prostheses - other
Device Class
Class IIb
Medical Purpose
The prosthesis contained within the THD SphinKeeper Self Expandable Implant is intended to be implanted in the intersphincteric groove of the anal canal for the treatment of fecal incontinence (FI-Fecal Incontinence); the prostheis is implanted by using the corresponding THD SphinKeeper Delivery System

Manufacturer details

EUDAMED SRN
IT-PR-000029428

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Properties

  • Sterile