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0203030000

by Stryker Corp.

Ref 0203-030-000Model 08858251004422SW

0203030000 (0203-030-000) is a device classified as Class IIa in the EU and Class II in the US made by Stryker Corp., registered in EUDAMED on 24 Oct 2026 (Basic UDI-DI 08858251004422SW) and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 04546540184399), active as of 7 Nov 2026.

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

CE MDR

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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251004422SW Basic UDI-DI 04546540184399UDI-DIDate24 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04546540184399 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251004422SW registered 24 Oct 2026 Active
  • FDA GUDID UDI-DI 04546540184399 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04546540184399
  2. Registered EUDAMED 08858251004422SW

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  • Withdrawn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

Generic name
Surgical irrigation tubing set, single-use
Model / Ref / Catalog
08858251004422SW, 0203-030-000, 0203030000
Primary DI / UDI-DI
04546540184399
Basic UDI-DI
08858251004422SW
FDA product code
FQH
EMDN code
Z12019003 Wound treatment equipment
GMDN term
Surgical irrigation tubing set, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
880.5475
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
08858251004422SW
0203-030-000
GUDID
0203030000
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Surgical irrigation tubing set, single-use

Similar devices in this category

Other devices filed under WOUND TREATMENT EQUIPMENT.

Other devices from Stryker Corp.

See all devices from Stryker Corp. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)