Skip to content

Smop

by Swissmeda AG

Ref 07649997938014Model SMOP Version 2, 2INGIS Version 2, CAMLOG Version 2, MSOFT Version 2

Smop (07649997938014) is a dental treatment application software (EU MDR Class IIa; FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Swissmeda AG, registered in EUDAMED on 10 Jun 2025 (Basic UDI-DI 7649997938SDPSV2CV), cleared under FDA 510(k) K112251 on 25 Jan 2012 and listed in FDA GUDID since 9 Nov 2022 (UDI-DI 07649997938014), active as of 22 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 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K112251

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number7649997938SDPSV2CV Basic UDI-DI 07649997938014UDI-DIDate10 Jun 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number07649997938014 UDI-DI Date9 Nov 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK112251 Date25 Jan 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 7649997938SDPSV2CV registered 10 Jun 2025 Active
  • FDA 510(k) K112251 decided 25 Jan 2012 Active
  • FDA GUDID UDI-DI 07649997938014 listed 9 Nov 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K112251
  2. Listed FDA GUDID 07649997938014
  3. Registered EUDAMED 7649997938SDPSV2CV

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  • Withdrawn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

Trade name
Smop EUDAMED
Swissmeda Dental Planning System GUDID
Generic name
Dental treatment application software
Model / reference
SMOP Version 2 EUDAMED
2INGIS Version 2 EUDAMED
CAMLOG Version 2 EUDAMED
MSOFT Version 2 EUDAMED
07649997938014 EUDAMED
2.21.0 GUDID
Primary DI / UDI-DI
07649997938014
Basic UDI-DI
7649997938SDPSV2CV
510(k) Number
FDA product code
LLZ
EMDN code
Z11039082 Various radiodiagnostic and interventional instruments - software accessories
GMDN term
Dental treatment application software
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.2050
Special device type
Software
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
SMOP Version 2, 2INGIS Version 2, CAMLOG Version 2, MSOFT Version 2
07649997938014
GUDID
2.21.0
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.

Manufacturer details

EUDAMED SRN
CH-MF-000031883
Authorised representative
TROPHY FR-AR-000001797

Similar devices in this category

Other devices filed under VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - SOFTWARE ACCESSORIES.

Other devices from Swissmeda AG

See all devices from Swissmeda AG →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (22, all answered No)