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Vistarmed V0015C

by Shenzhen Vistar Medical Supplies Co., Ltd.

Part of a family of 208 devices: see the family page

Ref V0015C-HP Female

Vistarmed V0015C is a device classified as Class I in the EU and Class II in the US made by Shenzhen Vistar Medical Supplies Co., Ltd., registered in EUDAMED on 5 Dec 2025 (Basic UDI-DI 697352187RBPCPK), cleared under FDA 510(k) K152468 on 29 Oct 2015 and listed in FDA GUDID since 27 Oct 2022 (UDI-DI 96973521876690), 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) K152468

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 Number697352187RBPCPK Basic UDI-DI 96973521876690UDI-DIDate5 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number96973521876690 UDI-DI Date27 Oct 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK152468 Date29 Oct 2015DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 697352187RBPCPK registered 5 Dec 2025 Active
  • FDA 510(k) K152468 decided 29 Oct 2015 Active
  • FDA GUDID UDI-DI 96973521876690 listed 27 Oct 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K152468
  2. Listed FDA GUDID 96973521876690
  3. Registered EUDAMED 697352187RBPCPK

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  • Withdrawn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
Reusable Blood Pressure Cuff EUDAMED
Vistarmed GUDID
Generic name
Blood pressure cuff, reusable
Model / reference
V0015C-HP Female EUDAMED
V0015C GUDID
Primary DI / UDI-DI
96973521876690
Basic UDI-DI
697352187RBPCPK
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
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
V0015C-HP Female
GUDID
V0015C
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 (K152468)

and 8 more cleared under K152468

Similar devices in this category

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

Other devices from Shenzhen Vistar Medical Supplies Co., Ltd.

  • Vistarmed V0111C-DM

    Class II

  • Vistarmed V0014C-HPM

    Class II

  • Vistarmed V1011N-HP

    Class II

  • Vistarmed V1015N-HP

    Class II

See all devices from Shenzhen Vistar Medical Supplies Co., Ltd. →

Properties

  • Reusable
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (20, all answered No)