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StaClear SC250LL

by Staclear, Inc.

Ref SC250LL

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++B994SC250LLPR Basic UDI-DI B994SC250LL0UDI-DIDate3 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberB994SC250LL0 UDI-DI Date21 Sep 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  • Withdrawn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 Syringe EUDAMED
StaClear GUDID
Generic Name
General-purpose syringe/needle
Model / Ref / Catalog
SC250LL
Primary DI / UDI-DI
B994SC250LL0
Basic UDI-DI
++B994SC250LLPR
FDA Product Code
QLY, FMF
EMDN Code
A020102020102 Infusion and irrigation syringes, luer lock cone, 3-piece without needle, single-use
GMDN Term
General-purpose syringe/needle
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
880.5860
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 0.25 Milliliter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
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