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Pixa 85-10-5101

by Santa Barbara Imaging Systems, Inc.

Ref 85-10-5101

Pixa 85-10-5101 is a device classified as Class I in the EU and Class II in the US made by Santa Barbara Imaging Systems, Inc., registered in EUDAMED on 22 Oct 2024 (Basic UDI-DI 0812231038X-10-XXXXWW) and listed in FDA GUDID since 28 Aug 2024 (UDI-DI 00812231033852), 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 Number0812231038X-10-XXXXWW Basic UDI-DI 00812231033852UDI-DIDate22 Oct 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00812231033852 UDI-DI Date28 Aug 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0812231038X-10-XXXXWW registered 22 Oct 2024 Active
  • FDA GUDID UDI-DI 00812231033852 listed 28 Aug 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00812231033852
  2. Registered EUDAMED 0812231038X-10-XXXXWW

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  • Withdrawn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
Pixa
Generic name
Endoscope video camera
Device name
4K HDR Camera System
Model / reference
85-10-5101
Primary DI / UDI-DI
00812231033852
Basic UDI-DI
0812231038X-10-XXXXWW
Direct marketing DI
00812231033852
FDA product code
GCJ
EMDN code
Z12020405 Surgical cameras
GMDN term
Endoscope video camera
Device class
Class I EUDAMED
Class II GUDID
Regulation number
876.1500
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Related devices

Category: Endoscope video camera

Other devices from Santa Barbara Imaging Systems, Inc.

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Properties

  • Sterilise before use
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)