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Ultrasonic Tabletop Doppler, Models SD5 and SD6

by Edan Instruments, Inc.

510(k) K092997Ref SD6

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

CE MDR 510(k)

Valid until

Not listed

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

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K092997↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69444138SD5SUD Basic UDI-DIDate29 Jan 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06944413800809 UDI-DIDate1 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK092997 Date10 Nov 2009ClearedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Trade Name
Ultrasonic TableTop Doppler
Generic Name
Foetal Doppler system
Model / Reference
SD6
Primary DI / UDI-DI
06944413800809
Basic UDI-DI
69444138SD5SUD
510(k) Number
FDA Product Code
KNG
EMDN Code
Z12080103 Foetal heartbeat detectors
GMDN Term
Foetal Doppler system
Device Class
Class IIa EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 884.2660
Market of Registration
Germany
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution

Truth per registry

3 sources · 2 fields differ

FieldEUDAMED510(k)GUDID
510(k) NumberEUDAMED
n/a
510(k)
K092997
GUDID
K153475
Device ClassEUDAMED
Class IIa
510(k)
Class II
GUDID
Class II

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Ultrasonic Tabletop Doppler, Models SD5 and SD6, is a Class II medical device classified as a Monitor, Ultrasonic, Fetal under FDA nomenclature. It employs continuous-wave (CW) Doppler transducers (2 MHz or 3 MHz) to non-invasively detect and monitor fetal heart rate (FHR) during obstetric care, providing real-time audio and visual feedback for clinical assessment.

This device is designed for single-use or reusable application in obstetrics/gynecology settings, adhering to FDA 510(k) clearance (K092997) and MDR compliance. Supplied as a portable tabletop unit, it includes a wireless probe for remote fetal heart sound detection, with recorded playback capabilities for up to 240 seconds. Sterility and MRI safety are not specified, and regulatory authorizations are limited to the stated FDA and MDR filings.

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Properties

  • Measuring Function
  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No