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Scanmate Flex

by DGH Technology, Inc.

Ref FLEX

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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K171301↗

FDA record

Trust

Unverified

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

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00857377006117 Basic UDI-DI 00857377006117UDI-DIDate18 Aug 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number00857377006117 UDI-DI Date5 Sep 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK171301 Date31 Jul 2017IssuedStatusActive

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  • Withdrawn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/MDD Active

Specification

EUDAMED · 510(k) · GUDID

Trade Name
Scanmate Flex EUDAMED
Scanmate Flex USB Interface GUDID
Generic Name
Ophthalmic ultrasound imaging transducer
Model / Reference
FLEX EUDAMED
Scanmate Flex GUDID
Primary DI / UDI-DI
00857377006117
Basic UDI-DI
B-00857377006117
510(k) Number
FDA Product Code
ITX, IYO
EMDN Code
Z11040199 Ultrasound scanners - other
GMDN Term
Ophthalmic ultrasound imaging transducer
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.1570, 892.1560
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
FLEX
GUDID
Scanmate Flex
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000008833
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Dgh Technology Inc.

See all devices from Dgh Technology Inc. →

Properties

  • Measuring Function
  • Prescription Use
  • Serial Number

Other properties (19)

  • 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
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No