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1 ml 3 Dose Luer Lock Syringe / 125

by Bimed Teknik Aletler Sanayi ve Ticaret A.Ş.

Ref 3DG125

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K250733↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8682747SYR-01BF Basic UDI-DI 08682747029296UDI-DIDate9 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08682747029296 UDI-DI Date2 Sep 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK250733 Date3 Jul 2025IssuedStatusActive

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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k) · GUDID

Trade Name
1 ml 3 Dose Luer Lock Syringe / 125 EUDAMED
3Dose 1ml Syringe GUDID
Generic Name
General-purpose syringe, single-use
Device Name
Disposable Sterile Syringe (without needle)
Model / Reference
3DG125
Primary DI / UDI-DI
08682747029296
Basic UDI-DI
8682747SYR-01BF
510(k) Number
FDA Product Code
FMF
EMDN Code
A02010499 Syringes for injector, single-use - other
GMDN Term
General-purpose syringe, single-use
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
880.5860
EU market of registration
Türkiye
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
TR-MF-000038280

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Properties

  • Sterile
  • Single Use
  • Administering Medicine
  • Measuring Function
  • Prescription Use
  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No