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Zestaw do procedur inwazyjnych

by Su Biyomedikal Sistemler ve Sağlık Hizmetleri Sanayi ve Ticaret Anonim Şirketi

Ref SKT-513Model SET 11

Active European Union

CE MDD

Valid until

No date given

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 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08684382906246 Basic UDI-DI 08684382906246UDI-DIDate2 Nov 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  • Withdrawn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/MDD Active

Specification

EUDAMED

Model / reference
SET 11, SKT-513
Primary DI / UDI-DI
08684382906246
Basic UDI-DI
B-08684382906246
EMDN code
T0202 Surgical procedural kits (excluding surgical instrument kits)
Device class
Class IIa
EU registration type
Legacy device (under a directive)
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
TR-MF-000017528

Other devices from Su Biyomedikal Sistemler Ve Saglik Hizmetleri Sanayi Ve Ticaret Anonim Sirketi

See all devices from Su Biyomedikal Sistemler Ve Saglik Hizmetleri Sanayi Ve Ticaret Anonim Sirketi →

Properties

  • Supplied sterile

Other properties (13)

  • Sterilise before use: No
  • Implantable: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No