Skip to content

Na Ty-35 Bpeo

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

Ref TY-35 BPEO

Product code PNREMDN A020108

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number694515574001HU Basic UDI-DIDate4 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number06945155741436 UDI-DIDate20 Feb 2024ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Trade Name
Na
Generic Name
ENFit oral/enteral syringe, single-use
Device Name
Oral/Enteral Syringe
Model / Ref / Catalog
TY-35 BPEO
Primary DI / UDI-DI
06945155741436
Basic UDI-DI
694515574001HU
Direct Marketing DI
06945155741436
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
Market of Registration
Poland
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: ENFit oral/enteral syringe, single-use

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
  • 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

Sources (2)

  • FDA UDI 98562532-797b-406e-9594-03b088366963 34 fields · synced 22 Oct 2026
  • EUDAMED 06945155741436|694515574001HU 61 fields · synced 15 Oct 2026