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Ultra-Fine SAFETY Insulin Syringes

by embecta Medical II LLC 4 variants

Ref 305935Model Blister

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number30383017593538 UDI-DI Date21 Jul 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number0383017SFTYINSYRNGAC Basic UDI-DI 30383017593538UDI-DIDate9 Jul 2026RegisteredStatusActive

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  • Withdrawn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

Trade Name
Ultra-Fine SAFETY Insulin Syringes EUDAMED
Ultra-Fine SAFETY GUDID
Generic Name
Insulin syringe/needle, basic
Model / Ref / Catalog
Blister, 305935
Primary DI / UDI-DI
30383017593538 EUDAMED
10383017593510 GUDID
Basic UDI-DI
0383017SFTYINSYRNGAC
Unit of Use DI
80383017593588
FDA Product Code
MEG, FMF
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
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution
Size
Needle Gauge — 29 Gauge
Length — 12.7 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
30383017593538
GUDID
10383017593510
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000044225
Authorised representative
embecta Penel Limited IE-AR-000040945

Other devices from embecta Medical II LLC

See all devices from embecta Medical II LLC →

Properties

  • 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