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HAD1717MC

by H&abyz Co., Ltd.

Ref HAD1717MC, HAD1717MG

HAD1717MC is a device classified as Class IIa in the EU and Class II in the US made by H&abyz Co., Ltd., registered in EUDAMED on 15 Oct 2025 (Basic UDI-DI 88000704HAAP-17S), cleared under FDA 510(k) K200018 on 31 Jan 2020 and listed in FDA GUDID since 7 Apr 2023 (UDI-DI 08800070400012), active as of 21 Oct 2026.

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

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 21 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K200018

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 21 Oct 2026.

Regulatory status

as of registry sync 21 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number88000704HAAP-17S Basic UDI-DI 08800070400012UDI-DIDate15 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number08800070400012 UDI-DI Date7 Apr 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK200018 Date31 Jan 2020DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 88000704HAAP-17S registered 15 Oct 2025 Active
  • FDA 510(k) K200018 decided 31 Jan 2020 Active
  • FDA GUDID UDI-DI 08800070400012 listed 7 Apr 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K200018
  2. Listed FDA GUDID 08800070400012
  3. Registered EUDAMED 88000704HAAP-17S

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Generic name
Indirect flat panel x-ray detector
Model / reference
HAD1717MC, HAD1717MG
Primary DI / UDI-DI
08800070400012
Basic UDI-DI
88000704HAAP-17S
510(k) Number
FDA product code
MQB
EMDN code
Z11031180 Systems for direct digital radiology (dr) - hardware accessories
GMDN term
Indirect flat panel x-ray detector
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.1680
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
HAD1717MC, HAD1717MG
GUDID
HAD1717MC
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Indirect flat panel x-ray detector

Similar devices in this category

Other devices filed under SYSTEMS FOR DIRECT DIGITAL RADIOLOGY (DR) - HARDWARE ACCESSORIES.

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Properties

  • Prescription use
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)