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SnapshotNIR

by Kent Imaging Inc.

Ref KD205

SnapshotNIR (KD205) is a device classified as Class IIa in the EU and Class II in the US made by Kent Imaging Inc, registered in EUDAMED on 10 Feb 2025 (Basic UDI-DI ++B376KD205TQ), cleared under FDA 510(k) K201976 on 10 Nov 2020 and listed in FDA GUDID since 5 Apr 2024 (UDI-DI B376KD2050), active as of 7 Nov 2026. One FDA recall is linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K201976↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++B376KD205TQ Basic UDI-DI B376KD2050UDI-DIDate10 Feb 2025RegisteredStatusActive
United StatesGUDID listing GUDID NumberB376KD2050 UDI-DI Date5 Apr 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK201976 Date10 Nov 2020IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI ++B376KD205TQ registered 10 Feb 2025 Active
  • FDA 510(k) K201976 decided 10 Nov 2020 Active
  • FDA GUDID UDI-DI B376KD2050 listed 5 Apr 2024 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0789-2024 FDA Class II initiated 30 Oct 2023

    Tissue oxygenation measurement system touchscreens may be unresponsive, which may prevent the viewing of oxygenation images.

Timeline

4 dated events

  1. Cleared FDA 510(k) K201976
  2. Recall initiated FDA recalls Z-0789-2024
  3. Listed FDA GUDID B376KD2050
  4. Registered EUDAMED ++B376KD205TQ

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k) · GUDID

Generic name
Tissue saturation oximeter
Model / Ref / Catalog
KD205, KD205CE/KD205UC
Primary DI / UDI-DI
B376KD2050
Basic UDI-DI
++B376KD205TQ
FDA product code
MUD
EMDN code
Z12040199 General medicine diagnosis and monitoring instruments - other
GMDN term
Tissue saturation oximeter
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
870.2700
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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.

Manufacturer details

EUDAMED SRN
CA-MF-000042637
Authorised representative
Obelis s.a. BE-AR-000000106

Similar devices in this category

Other devices filed under GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - OTHER.

Other devices from Kent Imaging Inc

See all devices from Kent Imaging Inc →

Properties

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