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Arm blood pressure monitor

by Guangdong Xinyu Electronic and Technology Co., Ltd.

Ref XY-B07Model XY-B01、XY-B02、XY-B03、XY-B05、XY-B07、XY-B08、XY-B09

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06977093190052 UDI-DI Date1 Jun 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number697709319XYarm9L Basic UDI-DI 06977093190052UDI-DIDate20 Dec 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 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Model / Reference
XY-B01、XY-B02、XY-B03、XY-B05、XY-B07、XY-B08、XY-B09, XY-B07
Primary DI / UDI-DI
06977093190052
Basic UDI-DI
697709319XYarm9L
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-000025849
Authorised representative
Share info GmbH DE-AR-000005132

Other devices from Guangdong Xinyu Electronic and Technology Co., Ltd.

See all devices from Guangdong Xinyu Electronic and Technology Co., Ltd. →

Properties

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

Other properties (20)

  • 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
  • Expiration Date: No
  • Manufacturing Date: No