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Electronic blood pressure monitor

by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

Ref YE8300B, YE660DModel YE660D, YE610D, YE610F, YEC30, YEC31, YEC60510(k) K170605

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

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) K170605↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number693325791015HA Basic UDI-DI Date29 Nov 2024RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK170605 Date27 Mar 2018ClearedStatusActive

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 24 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  • Withdrawn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)

Model / Reference
YE8300B, YE660D, YE610D, YE610F, YEC30, YEC31, YEC60
Primary DI / UDI-DI
06933257910157, 06933257940529, 06933257923911, 06933257913004, 06933257923942
Basic UDI-DI
693325791015HA, 693325792246J6
Direct Marketing DI
06933257910157
06933257940529
06933257923911
06933257913004
06933257923942
510(k) Number
FDA Product Code
DXN
EMDN Code
Z1203020501 Non–invasive oscillometric blood pressure gauges
Device Class
Class IIa EUDAMED
Class II 510(k)
Regulation
21 CFR Part 870.1130
EU market of registration
Poland
Spain
Italy
Slovakia
Austria
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Truth per registry

2 sources · 1 field differs

FieldEUDAMED510(k)
Device ClassEUDAMED
Class IIa
510(k)
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000012834
Authorised representative
Metrax GmbH DE-AR-000005481

Other devices from Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

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Properties

  • Measuring Function

Other properties (12)

  • Sterile: 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