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Orantech BPD-20TS-W08

by Orantech Inc.

Part of a family of 351 devices: see the family page

Ref BPD-20TS-W08

Orantech BPD-20TS-W08 is a device classified as Class I in the EU and Class II in the US made by Orantech Inc., registered in EUDAMED on 15 Nov 2023 (Basic UDI-DI 69416919ORANTECH06QZ), cleared under FDA 510(k) K173197 on 21 Aug 2018 and listed in FDA GUDID since 17 Oct 2022 (UDI-DI 06941691900535), 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) K173197

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 Number69416919ORANTECH06QZ Basic UDI-DI 06941691900535UDI-DIDate15 Nov 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number06941691900535 UDI-DI Date17 Oct 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK173197 Date21 Aug 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 69416919ORANTECH06QZ registered 15 Nov 2023 Active
  • FDA 510(k) K173197 decided 21 Aug 2018 Active
  • FDA GUDID UDI-DI 06941691900535 listed 17 Oct 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K173197
  2. Listed FDA GUDID 06941691900535
  3. Registered EUDAMED 69416919ORANTECH06QZ

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  • Withdrawn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
NIBP cuff EUDAMED
Orantech GUDID
Generic name
Blood pressure cuff, single-use
Model / reference
BPD-20TS-W08
Description
TPU, Single tube, With connector Infant Range 9.0-14.8cm
Primary DI / UDI-DI
06941691900535
Basic UDI-DI
69416919ORANTECH06QZ
510(k) Number
FDA product code
DXQ
EMDN code
Z1203020285 Multi-parameter monitors - consumables
GMDN term
Blood pressure cuff, single-use
Device class
Class I EUDAMED
Class II GUDID
Regulation number
870.1120
EU registration type
Standard device
EU market of registration
Denmark
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

Cleared under the same submission (K173197)

and 8 more cleared under K173197

Similar devices in this category

Other devices filed under MULTI-PARAMETER MONITORS - CONSUMABLES.

Other devices from Orantech Inc.

See all devices from Orantech Inc. →

Properties

  • Single use
  • Reusable
  • Measuring function
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)