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EcoVue

by HR HealthCare 8 variants

Ref 281

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

CE MDR

Valid until

29 Mar 2028

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier Intertek Medical Notified Body AB

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
European UnionCE/MDR EUDAMED Number8620259250 Date15 Oct 2026IssuedStatusActive expires 29 Mar 2028
United StatesGUDID listing GUDID Number00851809002814 UDI-DI Date16 Jul 2018ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

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  • Withdrawn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
Skin topical coupling gel
Device Name
EcoVue Ultrasound Gel
Model / Ref / Catalog
281
Primary DI / UDI-DI
00851809002814
Basic UDI-DI
851809002ECOVUEDC
FDA Product Code
MUI
EMDN Code
V9099 Various devices not included in other classes - other
GMDN Term
Skin topical coupling gel
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
892.1570
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Weight — 20 Gram

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000008639
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from HR HealthCare

See all devices from HR HealthCare →

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (20)

  • 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No