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Transcranial Doppler Ultrasound System

by Shenzhen Delica Medical Equipment Co., Ltd. 4 variants

Ref /Model EMS-9PB

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

CE MDD 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) K213009↗

+2 more

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 StatesFDA 510(k) 510(k) NumberK213009 Date8 Jul 2022IssuedStatusActive
European UnionCE/MDD EUDAMED NumberB-06970481940048 Basic UDI-DI 06970481940048UDI-DIDate15 Jun 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number06970481940048 UDI-DI Date19 Sep 2016ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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/MDD Active

Specification

EUDAMED · 510(k) · GUDID

Trade Name
Transcranial Doppler Ultrasound System EUDAMED
Delica GUDID
Generic Name
Noninvasive vascular ultrasound system, line-powered
Model / Reference
EMS-9PB, /
Primary DI / UDI-DI
06970481940048
Basic UDI-DI
B-06970481940048
510(k) Number
FDA Product Code
OQQ, IYN, ITX
EMDN Code
Z11040101 Internal ultrasound scanners
GMDN Term
Noninvasive vascular ultrasound system, line-powered
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.1570, 892.1550
EU market of registration
Italy
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-000022543
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Shenzhen Delica Medical Equipment Co., Ltd.

See all devices from Shenzhen Delica Medical Equipment Co., Ltd. →

Properties

  • Prescription Use
  • Convenience Kit
  • Combination Product
  • Serial Number
  • Manufacturing Date

Other properties (17)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No