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Hokanson 03745

by D. E. Hokanson, Inc.

Ref UDC1.6

Hokanson 03745 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 00817065020702D9), cleared under FDA 510(k) K041689 on 6 Aug 2004 and listed in FDA GUDID since 9 Sep 2016 (UDI-DI 00817065020702), active as of 24 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 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number00817065020702D9 Basic UDI-DI 00817065020702UDI-DIDate10 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00817065020702 UDI-DI Date9 Sep 2016ListedStatusListed 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 00817065020702D9 registered 10 Sep 2026 Active
  • FDA 510(k) K041689 decided 6 Aug 2004 Active
  • FDA GUDID UDI-DI 00817065020702 listed 9 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K041689
  2. Listed FDA GUDID 00817065020702
  3. Registered EUDAMED 00817065020702D9

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  • Withdrawn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
Device name
1.6 x 9 cm digit vascular cuff- 1/4 Turn Connector Connector
Model / Ref / Catalog
UDC1.6 EUDAMED
03745 GUDID
Primary DI / UDI-DI
00817065020702
Basic UDI-DI
00817065020702D9
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
Length — 9 Centimeter
Width — 1.6 Centimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
UDC1.6
GUDID
03745
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)