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Statlock

by C. R. Bard, Inc. 3 variants

Ref FOL0100CE

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 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0801741JSXBCROO3C Basic UDI-DI 00801741076084UDI-DIDate28 Oct 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  • Withdrawn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
StatLock Foley Stabilization Device Procedure Pack
Model / Reference
FOL0100CE
Primary DI / UDI-DI
00801741076084
Basic UDI-DI
0801741JSXBCROO3C
EMDN Code
U0180 Urethral prostatic and bladder catheters - accessories
Device Class
Class I
Medical Purpose
StatLock Foley Stabilization Device Procedure Packs are intended to secure a compatible urinary catheter to prevent traction. The Skin Prep Pad is used to protect the skin prior to applying an adhesive bandage.

Manufacturer details

EUDAMED SRN
US-PR-000037901

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Properties

Other properties (1)

  • Sterile: No