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Spitze für Urin-Monovette®

by SARSTEDT AG & Co.KG

Ref 10.251

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

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

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
United StatesGUDID listing GUDID Number04038917080941 UDI-DI Date31 Aug 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/IVDR EUDAMED Number4038917SARTD00400U5K Basic UDI-DI 04038917080941UDI-DIDate28 Aug 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Spitze für Urin-Monovette® EUDAMED
Collection Tip F/ Monv-U 76X8 GUDID
Generic Name
Non-evacuated urine specimen container IVD, no additive
Device Name
Urin-Monovette® Unsteril
Model / Ref / Catalog
10.251
Primary DI / UDI-DI
04038917080941
Basic UDI-DI
4038917SARTD00400U5K
Unit of Use DI
04038917163330
FDA Product Code
NNK
EMDN Code
W05010202 Urine collection, tubes
GMDN Term
Non-evacuated urine specimen container IVD, no additive
Device Class
Class A EUDAMED
Class I GUDID
Regulation Number
864.3250
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class A
GUDID
Class I

Manufacturer details

EUDAMED SRN
DE-MF-000005649

Other devices from Sarstedt AG & Co. KG

See all devices from Sarstedt AG & Co. KG →

Properties

  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (20)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No