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Ophtalmology Surgery Pack

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

Ref OPSP-010Model SET 37 - Göz Örtü Seti/Oftalmik Örtü Seti/Lazer Göz Örtü Seti Eye Drape Set/Ophtalmic Drape Set/Laser Eye Drape Set

Active European Union

CE MDD

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08682780975932 Basic UDI-DI 08682780975932UDI-DIDate15 Oct 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  • Withdrawn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 37 - Göz Örtü Seti/Oftalmik Örtü Seti/Lazer Göz Örtü Seti Eye Drape Set/Ophtalmic Drape Set/Laser Eye Drape Set, OPSP-010
Primary DI / UDI-DI
08682780975932
Basic UDI-DI
B-08682780975932
EMDN Code
T020199 Surgical drapes - other
Device Class
Class I
EU market of registration
Romania

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

  • Sterile

Other properties (12)

  • 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