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Oral/Enteral Syringe

by Ningbo Tianyi Medical Appliance Co., Ltd. 14 variants

Ref TY-60 BOEO

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number694515574001HU Basic UDI-DI 06945155741283UDI-DIDate4 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number06945155741283 UDI-DI Date20 Feb 2024ListedStatusListed GUDID: in commercial distribution

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

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
ENFit oral/enteral syringe, single-use
Device Name
Oral/Enteral Syringe
Model / Ref / Catalog
TY-60 BOEO
Primary DI / UDI-DI
06945155741283
Basic UDI-DI
694515574001HU
Direct Marketing DI
06945155741283
FDA Product Code
PNR
EMDN Code
A020108 Enteral feeding syringes
GMDN Term
ENFit oral/enteral syringe, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
876.5980
EU market of registration
Slovakia
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

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

  • Single Use
  • Administering Medicine
  • HCT/P
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (18)

  • 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • Premarket Exempt: No
  • Serial Number: No