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StaClear SC250LS

by Staclear, Inc.

Ref SC250LS

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++B994SC250LSQ7 Basic UDI-DI B994SC250LS0UDI-DIDate3 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberB994SC250LS0 UDI-DI Date8 Aug 2022ListedStatusListed 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  • Withdrawn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 / Reference
SC250LS
Primary DI / UDI-DI
B994SC250LS0
Basic UDI-DI
++B994SC250LSQ7
FDA Product Code
QLY, FMF
EMDN Code
A020102010202 Infusion and irrigation syringes, luer 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