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Disposable Endoscope Injection Needles

by Zhuji Pengtian Medical Instrument Co., Ltd FDA registration: China EUDAMED

Ref PTI-2318-2306-B EMDN G03020101

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06950190417451 Basic UDI-DIDate22 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Disposable Endoscope Injection Needles
Model / Reference
PTI-2318-2306-B
Primary DI / UDI-DI
06950190417451
Basic UDI-DI
B-06950190417451
EMDN Code
G03020101 Digestive endoscopy, single-lumen needles
Device Class
Class IIa
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
CN-MF-000013084
Authorised representative
Meditech X-Ray Spółka z o.o. PL-AR-000002989

Other devices from Zhuji Pengtian Medical Instrument Co., Ltd.

See all devices from Zhuji Pengtian Medical Instrument Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (10)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 06950190417451|B-06950190417451 61 fields · synced 25 Oct 2026