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S-Monovette®-Needle 23Gx1" 85.1442

by Sarstedt Aktiengesellschaft & Co.KG

Ref 85.1442

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4038917SARTD04000S5X Basic UDI-DI 04038917530552UDI-DIDate12 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04038917530552 UDI-DI Date22 Oct 2025ListedStatusListed 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  • Withdrawn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
S-Monovette®-Kanüle 23Gx1" EUDAMED
S-Monovette®-Needle 23Gx1" GUDID
Generic Name
Non-fixed blood collection needle
Device Name
S-Monovette® (Safety-) Kanüle
Model / Ref / Catalog
85.1442
Primary DI / UDI-DI
04038917530552
Basic UDI-DI
4038917SARTD04000S5X
Unit of Use DI
04038917530569
FDA Product Code
JKA
EMDN Code
A01010502 Needles for collection under vacuum, w/o safety systems
GMDN Term
Non-fixed blood collection needle
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
862.1675
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

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Properties

  • Sterile
  • Single Use
  • Premarket Exempt

Other properties (21)

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