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Add HAD1417MCW

by H&abyz Co., Ltd.

Ref ADD(HAD1417MCW)

Add HAD1417MCW 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 24 Apr 2026 (Basic UDI-DI 88000704ADDTE) and listed in FDA GUDID since 7 Apr 2023 (UDI-DI 08800070400005), active as of 23 Oct 2026.

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

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number88000704ADDTE Basic UDI-DI 08800070400005UDI-DIDate24 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800070400005 UDI-DI Date7 Apr 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 88000704ADDTE registered 24 Apr 2026 Active
  • FDA GUDID UDI-DI 08800070400005 listed 7 Apr 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08800070400005
  2. Registered EUDAMED 88000704ADDTE

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  • Withdrawn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

Trade name
Add
Generic name
Indirect flat panel x-ray detector
Device name
Digital flat panel X-ray detector
Model / Ref / Catalog
ADD(HAD1417MCW) EUDAMED
HAD1417MCW GUDID
Primary DI / UDI-DI
08800070400005
Basic UDI-DI
88000704ADDTE
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
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
ADD(HAD1417MCW)
GUDID
HAD1417MCW
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.

Other devices from H&abyz Co., Ltd.

  • A1417MCW

    Class II

  • A1717MCW

    Class II

  • HAD1717MC

    Class II

  • HnX-PB

    Class II

See all devices from H&abyz Co., Ltd. →

Properties

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