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Sil-Fixx

by Conlett Technology Inc

Ref SF1915

Sil-Fixx (SF1915) is a Class I device made by Conlett Technology Inc, registered in EUDAMED on 12 Jan 2026 (Basic UDI-DI 697359601Sil-FixxGE), active as of 24 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

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

Source EUDAMED, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697359601Sil-FixxGE Basic UDI-DI 06973596010217UDI-DIDate12 Jan 2026RegisteredStatusActive

Official records

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  • Withdrawn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
Sil-Fixx 1.9cm x 1.5M
Model / reference
SF1915
Primary DI / UDI-DI
06973596010217
Basic UDI-DI
697359601Sil-FixxGE
Direct marketing DI
06973596010217
EMDN code
M04040701 Silicone dressings, non-combined
Device class
Class I
EU registration type
Standard device
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
CN-MF-000002101
Authorised representative
Lotus NL B.V. NL-AR-000000121

Similar devices in this category

Other devices filed under SILICONE DRESSINGS, NON-COMBINED.

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Properties

Other properties (14, all answered No)