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Pulsenmore ES

by Pulsenmore Ltd 3 variants

Ref 400-0001

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

CE MDR De Novo

Valid until

Not listed

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

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

De Novo DEN240074↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number7290018579PulsenmoreESLC Basic UDI-DI 07290018579008UDI-DIDate19 Jan 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290018579008 UDI-DI Date25 Nov 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA De Novo De Novo NumberDEN240074 Date31 Oct 2025IssuedStatusActive

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 24 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA De Novo Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k) · GUDID

Trade Name
Pulsenmore ES EUDAMED
Pulsenmore ES Type C GUDID
Generic Name
Hand-held ultrasound imaging system, body-surface
Device Name
Pulsemore ES
Model / Ref / Catalog
400-0001
Primary DI / UDI-DI
07290018579008
Basic UDI-DI
7290018579PulsenmoreESLC
Direct Marketing DI
07290018579008
De Novo Number
FDA Product Code
SGJ
EMDN Code
Z11040106 Handheld ultrasound scanners
GMDN Term
Hand-held ultrasound imaging system, body-surface
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.1590
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
IL-MF-000037891
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from Pulsenmore Ltd

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