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Hokanson UPC2.5™

by D. E. Hokanson, Inc.

Ref UPC2.5

Hokanson UPC2.5™ (43053) is a device classified as Class I in the EU and Class II in the US made by D. E. Hokanson, Inc., registered in EUDAMED on 10 Sep 2026 (Basic UDI-DI 00817065021860E3), cleared under FDA 510(k) K041689 on 6 Aug 2004 and listed in FDA GUDID since 18 Jul 2017 (UDI-DI 00817065021860), active as of 22 Oct 2026.

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

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K041689

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number00817065021860E3 Basic UDI-DI 00817065021860UDI-DIDate10 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00817065021860 UDI-DI Date18 Jul 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK041689 Date6 Aug 2004DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 00817065021860E3 registered 10 Sep 2026 Active
  • FDA 510(k) K041689 decided 6 Aug 2004 Active
  • FDA GUDID UDI-DI 00817065021860 listed 18 Jul 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K041689
  2. Listed FDA GUDID 00817065021860
  3. Registered EUDAMED 00817065021860E3

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  • Withdrawn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 · GUDID

Trade name
Hokanson
Generic name
Blood pressure cuff, reusable
Model / Ref / Catalog
UPC2.5 EUDAMED
UPC2.5™ GUDID
43053 GUDID
Primary DI / UDI-DI
00817065021860
Basic UDI-DI
00817065021860E3
510(k) Number
FDA product code
DXQ
EMDN code
Z1203020599 Non-invasive blood pressure gauges - other
GMDN term
Blood pressure cuff, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
870.1120
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Width — 2.5 Centimeter
Length — 12 Centimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
UPC2.5
GUDID
UPC2.5™
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Blood pressure cuff, reusable

Cleared under the same submission (K041689)

and 8 more cleared under K041689

Similar devices in this category

Other devices filed under NON-INVASIVE BLOOD PRESSURE GAUGES - OTHER.

Other devices from D. E. Hokanson, Inc.

See all devices from D. E. Hokanson, Inc. →

Properties

  • Lot / batch number
  • Manufacturing date
Other properties (23, all answered No)