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21IN-2003000001

by Set Medikal Sanayi ve Ticaret A.S - MF

Ref 21IN-2003000001Model Syringes without Hypodermic needles Luer 3 part

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
European UnionCE/MDR EUDAMED Number8699207STLS3PONY8 Basic UDI-DI 08699207320022UDI-DIDate8 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08699207320022 UDI-DI Date17 Mar 2026ListedStatusListed 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  • Withdrawn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

Trade Name
Set Inject
Generic Name
Metered-delivery hypodermic syringe
Model / Reference
Syringes without Hypodermic needles Luer 3 part, 21IN-2003000001
Primary DI / UDI-DI
08699207320022
Basic UDI-DI
8699207STLS3PONY8
FDA Product Code
FMF
EMDN Code
A020102010202 Infusion and irrigation syringes, luer cone, 3-piece without needle, single-use
GMDN Term
Metered-delivery hypodermic syringe
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
880.5860
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 20 Milliliter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
TR-MF-000028280

Other devices from Set Medikal Sanayi ve Ticaret A.S - MF

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Properties

  • Sterile
  • Single Use
  • Measuring Function
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No