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Inspire

by Good Doctors Co., Ltd.

Ref InspireModel IC-WHCD100

Inspire is an intraoral optical scanning system (EU MDR Class I; FDA Class II; FDA product code NBL, Laser, Fluorescence Caries Detection) made by Good Doctors Co., Ltd., registered in EUDAMED on 24 Jun 2024 (Basic UDI-DI 88000254WHCD100E6), cleared under FDA 510(k) K183471 on 2 Jul 2020 and listed in FDA GUDID since 13 Nov 2020 (UDI-DI 08800025400135), active as of 24 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K183471↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number88000254WHCD100E6 Basic UDI-DI 08800025400135UDI-DIDate24 Jun 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number08800025400135 UDI-DI Date13 Nov 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK183471 Date2 Jul 2020IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 88000254WHCD100E6 registered 24 Jun 2024 Active
  • FDA 510(k) K183471 decided 2 Jul 2020 Active
  • FDA GUDID UDI-DI 08800025400135 listed 13 Nov 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K183471
  2. Listed FDA GUDID 08800025400135
  3. Registered EUDAMED 88000254WHCD100E6

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Generic name
Intraoral optical scanning system
Device name
Intraoral camera
Model / reference
IC-WHCD100, Inspire
Primary DI / UDI-DI
08800025400135
Basic UDI-DI
88000254WHCD100E6
510(k) Number
FDA product code
NBL
EMDN code
Z12119080 Various dental stomatology instruments - hardware accessories
GMDN term
Intraoral optical scanning system
Device class
Class I EUDAMED
Class II GUDID
Regulation number
872.1745
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

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

Manufacturer details

EUDAMED SRN
KR-MF-000035314
Authorised representative
Good Doctors Germany GmbH DE-AR-000025472

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Properties

  • Serial number
Other properties (24, all answered No)