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KONIX - Y0000.101.0011 - NON-STERILE ULTRASOUND GEL - 5000 ml

by Turkuaz Sağlik Hi̇zmetleri̇ Medi̇kal Temi̇zli̇k Ki̇myasal Ürünler Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇ 31 variants

Ref NUG-0016, NUG-0006, NUG-0004, NUG-0010, NUG-0001, NUG-0018, NUG-0019, NUG-0017, NUG-0012, NUG-0014Model Y0000.101.0011

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 Number868171534101J8 Basic UDI-DI Date18 Feb 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  • Withdrawn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
KONIX - Y0000.101.0011 - NON-STERILE ULTRASOUND GEL - 5000 ml
Model / Reference
Y0000.101.0011, NUG-0016, NUG-0006, NUG-0004, NUG-0010, NUG-0001, NUG-0018, NUG-0019, NUG-0017, NUG-0012, NUG-0014
Primary DI / UDI-DI
08683229604284, 08681715349596, 08681715349572, 08681715349626, 08698712450293, 08681715349688, 08698712450026, 08683229604291, 08681715349664, 08683229600514, 08683229601344, 08698712450040, 08683229608664
Basic UDI-DI
868171534101J8
Direct Marketing DI
08683229604284
08681715349596
08681715349572
08681715349626
08698712450293
08681715349688
08698712450026
08683229604291
08681715349664
08683229600514
08683229601344
08698712450040
08683229608664
EMDN Code
Z1399 Non-specific consumables for diagnostic instruments - other
Device Class
Class I
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000015402

Other devices from Turkuaz Sağlik Hi̇zmetleri̇ Medi̇kal Temi̇zli̇k Ki̇myasal Ürünler Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇

See all devices from Turkuaz Sağlik Hi̇zmetleri̇ Medi̇kal Temi̇zli̇k Ki̇myasal Ürünler Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇ →

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