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Disposable Cuff 98-0400-00

by SunTech Medical, Inc

Ref 98-0400-00Model DC100

Disposable Cuff 98-0400-00 is a device classified as Class I in the EU and Class II in the US made by SunTech Medical, Inc, registered in EUDAMED on 30 Oct 2026 (Basic UDI-DI 084093510000000000DC100H9), cleared under FDA 510(k) K080854 on 20 Oct 2008 and listed in FDA GUDID since 12 Sep 2016 (UDI-DI 10840935102908), 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

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K080854

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number084093510000000000DC100H9 Basic UDI-DI 10840935102908UDI-DIDate30 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10840935102908 UDI-DI Date12 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Abbreviated NumberK080854 Date20 Oct 2008DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 084093510000000000DC100H9 registered 30 Oct 2026 Active
  • FDA 510(k) K080854 decided 20 Oct 2008 Active
  • FDA GUDID UDI-DI 10840935102908 listed 12 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-2277-2019 FDA Class II initiated 3 Jun 2019

    Product is mislabeled. The label on the package is for a size #4 cuff, but the incorrect size #3 cuff was placed in the package.

Timeline

4 dated events

  1. Cleared FDA 510(k) K080854
  2. Listed FDA GUDID 10840935102908
  3. Recall initiated FDA recalls Z-2277-2019
  4. Registered EUDAMED 084093510000000000DC100H9

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  • Withdrawn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
Disposable Cuff
Generic name
Blood pressure cuff, reusable
Device name
Disposable Blood Pressure Cuff
Model / reference
98-0400-00, DC100
Primary DI / UDI-DI
10840935102908
Basic UDI-DI
084093510000000000DC100H9
510(k) Number
FDA product code
DXQ
EMDN code
Z1203020302 Non–invasive blood pressure monitoring instruments
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

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Related devices

Category: Blood pressure cuff, reusable

Cleared under the same submission (K080854)

and 8 more cleared under K080854

Other devices from SunTech Medical, Inc

See all devices from SunTech Medical, Inc →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (22, all answered No)