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Wrist Blood Pressure monitor

by Shenzhen IMDK Medical Technology Co., Ltd.

Ref BPM-W1VL

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K253133↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06973912940419 UDI-DI Date23 Jun 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK253133 Date13 Feb 2026IssuedStatusActive
European UnionCE/MDR EUDAMED Number697391294801WSCB Basic UDI-DI 06973912940419UDI-DIDate24 Oct 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k) · GUDID

Trade Name
Wrist Blood Pressure monitor EUDAMED
Imdk GUDID
Generic Name
Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Model / Reference
BPM-W1VL
Primary DI / UDI-DI
06973912940419
Basic UDI-DI
697391294801WSCB
Direct Marketing DI
06973912940419
510(k) Number
FDA Product Code
DXN
EMDN Code
Z1203020302 Non–invasive blood pressure monitoring instruments
GMDN Term
Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.1130
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000024290
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Shenzhen IMDK Medical Technology Co., Ltd

See all devices from Shenzhen IMDK Medical Technology Co., Ltd →

Properties

  • Measuring Function
  • Over-the-Counter
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (18)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No