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Dental Procedure Pack

by Hanedan Sağlik Medi̇kal Sanayi̇ Ve Ti̇caret Anoni̇m

Ref HDN-141-01AModel STERILE DISPOSABLE SURGICAL GENERAL OPERATION DRAPE PROCEDURE PACK

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 Number0868444113SKDPP9F Basic UDI-DI 08685254901116UDI-DIDate13 Mar 2025RegisteredStatusActive

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  • Withdrawn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
Sterile Disposable Surgical General Operation Drape Procedure Pack
Model / Reference
STERILE DISPOSABLE SURGICAL GENERAL OPERATION DRAPE PROCEDURE PACK, HDN-141-01A
Primary DI / UDI-DI
08685254901116
Basic UDI-DI
0868444113SKDPP9F
Direct Marketing DI
08685254901116
EMDN Code
T0202 Surgical procedural kits (excluding surgical instrument kits)
Device Class
Class I
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000037144

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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