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Orbit K 98-0061-01

by SunTech Medical, Inc

Part of a family of 16 devices: see the family page

Ref 98-0061-01Model Stress100

Orbit K 98-0061-01 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 08409351000000STRESS100YY), cleared under FDA 510(k) K122401 on 2 Nov 2012 and listed in FDA GUDID since 12 Sep 2016 (UDI-DI 10840935100911), active as of 7 Nov 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 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K122401

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 Number08409351000000STRESS100YY Basic UDI-DI 10840935100911UDI-DIDate30 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10840935100911 UDI-DI Date12 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK122401 Date2 Nov 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08409351000000STRESS100YY registered 30 Oct 2026 Active
  • FDA 510(k) K122401 decided 2 Nov 2012 Active
  • FDA GUDID UDI-DI 10840935100911 listed 12 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K122401
  2. Listed FDA GUDID 10840935100911
  3. Registered EUDAMED 08409351000000STRESS100YY

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  • Withdrawn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
Orbit K
Generic name
Automatic-inflation electronic sphygmomanometer, non-portable
Device name
Orbit K Blood Pressure Cuff
Model / reference
98-0061-01, Stress100
Primary DI / UDI-DI
10840935100911
Basic UDI-DI
08409351000000STRESS100YY
510(k) Number
FDA product code
DXN
EMDN code
Z1203020302 Non–invasive blood pressure monitoring instruments
GMDN term
Automatic-inflation electronic sphygmomanometer, non-portable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
870.1130
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

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: Automatic-inflation electronic sphygmomanometer, non-portable

Cleared under the same submission (K122401)

and 8 more cleared under K122401

Similar devices in this category

Other devices filed under NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS.

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)