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Flyte 0408655001

by Stryker Corp.

Ref 0408-655-001Model 08858250000482S3

Flyte 0408655001 is a surgical helmet system (EU MDR Class I; FDA Class I; FDA product code FXZ, Helmet, Surgical) made by Stryker Corp., registered in EUDAMED on 3 Aug 2026 (Basic UDI-DI 08858250000482S3) and listed in FDA GUDID since 24 Sep 2018 (UDI-DI 07613154891061), active as of 25 Oct 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858250000482S3 Basic UDI-DI 07613154891061UDI-DIDate3 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613154891061 UDI-DI Date24 Sep 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858250000482S3 registered 3 Aug 2026 Active
  • FDA GUDID UDI-DI 07613154891061 listed 24 Sep 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613154891061
  2. Registered EUDAMED 08858250000482S3

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  • Withdrawn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

Trade name
Flyte
Generic name
Surgical helmet system
Device name
Personal Protective Equipment Battery Charger
Model / Ref / Catalog
08858250000482S3 EUDAMED
0408-655-001 EUDAMED
0408655001 GUDID
Primary DI / UDI-DI
07613154891061
Basic UDI-DI
08858250000482S3
Direct marketing DI
07613154891061
FDA product code
FXZ
EMDN code
Z12139082 Various orthopaedic and traumatology instruments - software accessories
GMDN term
Surgical helmet system
Device class
Class I
Regulation number
878.4040
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
08858250000482S3
0408-655-001
GUDID
0408655001

Related devices

Category: Surgical helmet system

Similar devices in this category

Other devices filed under VARIOUS ORTHOPAEDIC AND TRAUMATOLOGY INSTRUMENTS.

Other devices from Stryker Corp.

See all devices from Stryker Corp. →

Properties

  • Prescription use
  • Premarket exempt
  • Serial number
Other properties (22, all answered No)