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In-Light Camera P59109

by STRYKER Communications, Inc.

Ref P59109Model 08858251028116U6

In-Light Camera P59109 is a Class I device made by STRYKER Communications, Inc., registered in EUDAMED on 4 Nov 2026 (Basic UDI-DI 08858251028116U6) and listed in FDA GUDID since 27 Aug 2025 (UDI-DI 07613327661194), 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 Number08858251028116U6 Basic UDI-DI 07613327661194UDI-DIDate4 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327661194 UDI-DI Date27 Aug 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251028116U6 registered 4 Nov 2026 Active
  • FDA GUDID UDI-DI 07613327661194 listed 27 Aug 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613327661194
  2. Registered EUDAMED 08858251028116U6

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  • Withdrawn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
In-Light Camera
Generic name
Surgical video camera
Device name
COM_TF10468_StrykeCam4K
Model / Ref / Catalog
P59109, 08858251028116U6
Primary DI / UDI-DI
07613327661194
Basic UDI-DI
08858251028116U6
Direct marketing DI
07613327661194
FDA product code
KQM
EMDN code
Z12020405 Surgical cameras
GMDN term
Surgical video camera
Device class
Class I
Regulation number
878.4160
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Related devices

Category: Surgical video camera

Similar devices in this category

Other devices filed under SURGICAL CAMERAS.

Other devices from STRYKER Communications, Inc.

See all devices from STRYKER Communications, Inc. →

Properties

  • Premarket exempt
  • Serial number
Other properties (23, all answered No)