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EXENT® Mass Calibration Standard 1

by The Binding Site Group Ltd EUDAMEDGUDID

Active European Union

Ref MSS801.M

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number05051700020671 UDI-DIDate27 Nov 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/IVDR EUDAMED Number5051700MSS801.MJH Basic UDI-DIDate30 Aug 2023RegisteredStatusActive

Coverage

2 jurisdictions

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  • Withdrawn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

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.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 24 Oct 2026.

Specification

EUDAMED · GUDID

Generic Name
Mass spectrometry analyser calibration kit IVD
Model / Reference
MSS801.M
Primary DI / UDI-DI
05051700020671
Basic UDI-DI
5051700MSS801.MJH
FDA Product Code
OTA
EMDN Code
W0201020185 Automated immunochemistry analysers - consumables
GMDN Term
Mass spectrometry analyser calibration kit IVD
Device Class
Class A EUDAMED
Class II GUDID
Regulation Number
862.2570
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 II

Manufacturer details

EUDAMED SRN
UK-MF-000036707
Authorised representative
The Binding Site Ireland Limited IE-AR-000034426

Other devices from The Binding Site Group Ltd

See all devices from The Binding Site Group Ltd →

Properties

  • Animal Tissues
  • Professional Testing
  • New Device
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (17)

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