Skip to content

550-11

by Medtronic, Inc.

Ref 550-11

550-11 is a device classified as Class A in the EU and Class II in the US made by Medtronic, Inc., registered in EUDAMED on 28 Aug 2026 (Basic UDI-DI 0763000B000103272) and listed in FDA GUDID since 27 Mar 2023 (UDI-DI 00763000561826), active as of 25 Oct 2026.

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

CE IVDR

Valid until

No date given

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

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number0763000B000103272 Basic UDI-DI 00763000561826UDI-DIDate28 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00763000561826 UDI-DI Date27 Mar 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0763000B000103272 registered 28 Aug 2026 Active
  • FDA GUDID UDI-DI 00763000561826 listed 27 Mar 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00763000561826
  2. Registered EUDAMED 0763000B000103272

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  • Withdrawn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

Generic name
Multiple coagulation marker IVD, control
Device name
5 mL CaCl Solution
Model / reference
550-11
Primary DI / UDI-DI
00763000561826
Basic UDI-DI
0763000B000103272
FDA product code
GGN
EMDN code
W0580 IVD general use consumables devices - other accessories
GMDN term
Multiple coagulation marker IVD, control
Device class
Class A EUDAMED
Class II GUDID
Regulation number
864.5425
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 5.0 Milliliter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class A
GUDID
Class II

Device class is stated on each registry's own scale: Class A in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Multiple coagulation factor IVD, control

Similar devices in this category

Other devices filed under IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES.

Other devices from Medtronic, Inc.

See all devices from Medtronic, Inc. →

Properties

  • Near-patient testing
  • Professional testing
  • Premarket exempt
  • Lot / batch number
Other properties (22, all answered No)