Skip to content

Ultra-Fine SAFETY 305937

by embecta Medical II LLC United States EUDAMEDGUDID

Ref 305937Model Blister

Product code FMFEMDN A0201060301

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number30383017593736 UDI-DIDate21 Jul 2026ListedStatusIn distribution
European UnionCE/MDR EUDAMED Number0383017SFTYINSYRNGAC Basic UDI-DIDate9 Jul 2026RegisteredStatusActive

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 24 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 24 Oct 2026

Trade Name
Ultra-Fine SAFETY Insulin Syringes EUDAMED
Ultra-Fine SAFETY GUDID
Generic Name
Insulin syringe/needle, basic
Model / Ref / Catalog
305937, Blister
Primary DI / UDI-DI
30383017593736 EUDAMED
10383017593718 GUDID
Basic UDI-DI
0383017SFTYINSYRNGAC
Unit of Use DI
80383017593786
FDA Product Code
FMF, MEG
EMDN Code
A0201060301 Insulin syringes with safety systems and fixed needles, single-use
GMDN Term
Insulin syringe/needle, basic
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
880.5860
Market of Registration
Austria
Commercial Distribution
In Commercial Distribution
Size
Needle Gauge — 31 Gauge
Length — 8 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
30383017593736
GUDID
10383017593718
Device ClassEUDAMED
Class IIa
GUDID
Class II

Other devices from embecta Medical II LLC

See all devices from embecta Medical II LLC →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Single Use
  • Administering Medicine
  • Measuring Function
  • Over-the-Counter
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date
Other properties (16)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No

Sources (2)

  • FDA UDI 5f8fc133-dbba-46a3-aabd-7cc4cfdadb25 35 fields · synced 24 Oct 2026
  • EUDAMED 30383017593736|0383017SFTYINSYRNGAC 61 fields · synced 24 Oct 2026