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StaClear SC250AN

by Staclear, Inc.

Ref SC250AN

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

1 Nov 2029

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier Intertek Medical Notified Body AB

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 Number++B994SC250ANNU Basic UDI-DI B994SC250AN0UDI-DIDate3 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberB994SC250AN0 UDI-DI Date16 Aug 2023ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

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  • Withdrawn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
StaClear
Generic Name
General-purpose syringe/needle
Model / Ref / Catalog
SC250AN
Primary DI / UDI-DI
B994SC250AN0
Basic UDI-DI
++B994SC250ANNU
FDA Product Code
QLY, FMF, FMI
EMDN Code
A02010204 Infusion and irrigation syringes, without cone, with fixed needle, single-use
GMDN Term
General-purpose syringe/needle
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
880.5860, 880.5570
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 0.25 Milliliter
Needle Gauge — 31 Gauge
Length — 8 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Other devices from Staclear, Inc.

Properties

  • Sterile
  • Single Use
  • Administering Medicine
  • Measuring Function
  • Prescription Use
  • Lot / Batch Number
  • Expiration 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
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No