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Otoplan

by Cascination AG

Ref 20072

Otoplan (20072) is a device classified as Class IIa in the EU and Class II in the US made by CAScination AG, cleared under FDA 510(k) K242120 on 11 Apr 2025 (2 earlier submissions), registered in EUDAMED on 6 Oct 2021 (Basic UDI-DI 764016722300OPL001Z7) and listed in FDA GUDID since 19 Apr 2022 (UDI-DI 07640167220724), active as of 25 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K242120↗

+2 more

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k) 510(k) NumberK242120 Date11 Apr 2025IssuedStatusActive
United StatesGUDID listing GUDID Number07640167220724 UDI-DI Date19 Apr 2022ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number764016722300OPL001Z7 Basic UDI-DI Date6 Oct 2021RegisteredStatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K242120 decided 11 Apr 2025 Active· +2 more in the status table
  • EUDAMED Basic UDI-DI 764016722300OPL001Z7 registered 6 Oct 2021 Active
  • FDA GUDID UDI-DI 07640167220724 listed 19 Apr 2022 Listed

Timeline

5 dated events

  1. Cleared FDA 510(k) K203486
  2. Registered EUDAMED 764016722300OPL001Z7
  3. Listed FDA GUDID 07640167220724
  4. Cleared FDA 510(k) K220300
  5. Cleared FDA 510(k) K242120

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  • Withdrawn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
Radiology picture archiving and communication system workstation
Model / Ref / Catalog
20072, 1.3
Primary DI / UDI-DI
07640167220724, 07616962000205, 07640167222438, 07616962000304
Basic UDI-DI
764016722300OPL001Z7
Direct marketing DI
07616962000205
07640167222438
07616962000304
510(k) Number
FDA product code
QQE
EMDN code
Z12140592 Stereotactic ENT surgery instruments - medical device software
GMDN term
Radiology picture archiving and communication system workstation
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
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
20072
GUDID
1.3
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-000009927
Authorised representative
CAScination Deutschland GmbH DE-AR-000008247

Similar devices in this category

Other devices filed under ENT INSTRUMENTS.

Other devices from CAScination AG

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Properties

  • Measuring function
  • Prescription use
  • Manufacturing date
Other properties (22, all answered No)