Skip to content

Oral/Enteral Syringe with ENfit

by Ningbo Tianyi Medical Appliance Co., Ltd. United States EUDAMED

Ref TY-35 OEN

EMDN A020108

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number694515574000HS Basic UDI-DIDate4 Dec 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Oral/Enteral Syringe with ENfit
Model / Reference
TY-35 OEN
Primary DI / UDI-DI
06945155730232
Basic UDI-DI
694515574000HS
Direct Marketing DI
06945155730232
EMDN Code
A020108 Enteral feeding syringes
Device Class
Class IIa
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000029875
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Ningbo Tianyi Medical Appliance CO., Ltd.

See all devices from Ningbo Tianyi Medical Appliance CO., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Administering Medicine
Other properties (11)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 4ca8cf45-b0b8-4c95-b960-ac3ea713b32e 61 fields · synced 24 Oct 2026