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S-Monovette® 1.2ml FE

by SARSTEDT AG & Co.KG 3 variants

Ref 06.1665.001

Active European Union

CE IVDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 8 Nov 2026. What this means

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-04038917132848 Basic UDI-DI 04038917132848UDI-DIDate2 Nov 2026RegisteredStatusActive

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

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Device name
S-Monovette® Fluorid
Model / reference
06.1665.001
Primary DI / UDI-DI
04038917132848
Basic UDI-DI
B-04038917132848
EMDN code
W050101010201 Blood collection, tubes with additives or serum separator
Device class
Class IVD General
EU registration type
Legacy device (under a directive)
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000005649

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Properties

  • Supplied sterile

Other properties (12)

  • Sterilise before use: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains substances of microbial origin: No
  • Reagent: No
  • IVD kit: No
  • Self-testing: No
  • Near-patient testing: No
  • Professional testing: No
  • Companion diagnostics: No
  • IVD instrument: No
  • New device: No