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TraumaCad Mobile

by Brainlab Ltd.

Ref 07290109942001

TraumaCad Mobile (07290109942001) is a radiological PACS-dedicated management software (EU MDR Class IIa; FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Brainlab Ltd, registered in EUDAMED on 13 Apr 2026 (Basic UDI-DI 729010994TraumaCadRY) with CE/MDR certificate 3902756CE01 valid until 1 Sep 2028, cleared under FDA 510(k) K160001 on 12 Feb 2016 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 07290109942001), active as of 22 Oct 2026.

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

CE MDR 510(k)

Valid until

1 Sep 2028

CE MDR certificate

FDA recalls

None found

in data synced 22 Oct 2026

Documents

1 certificate

Certifier DEKRA Certification B.V.

510(k) K160001

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 Number729010994TraumaCadRY Basic UDI-DI 07290109942001UDI-DIDate13 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290109942001 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK160001 Date12 Feb 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 729010994TraumaCadRY registered 13 Apr 2026 Active· +1 more in the status table
  • FDA 510(k) K160001 decided 12 Feb 2016 Active
  • FDA GUDID UDI-DI 07290109942001 listed 23 Sep 2016 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 3902756CE01 Active Amended

    Quality management system EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    24 Oct 2025
    Expires
    1 Sep 2028
    Reason
    Mnf ar change

Timeline

5 dated events

  1. Cleared FDA 510(k) K160001
  2. Listed FDA GUDID 07290109942001
  3. Certificate issued EUDAMED 3902756CE01
  4. Registered EUDAMED 729010994TraumaCadRY
  5. Certificate expires EUDAMED 3902756CE01

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  • Withdrawn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
Radiological PACS-dedicated management software
Device name
TraumaCad
Model / reference
07290109942001 EUDAMED
2.0 GUDID
Primary DI / UDI-DI
07290109942001
Basic UDI-DI
729010994TraumaCadRY
510(k) Number
FDA product code
LLZ
EMDN code
Z12139082 Various orthopaedic and traumatology instruments - software accessories
GMDN term
Radiological PACS-dedicated management 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
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
07290109942001
GUDID
2.0
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
IL-MF-000008781
Authorised representative
AR Experts B.V. NL-AR-000023989

Similar devices in this category

Other devices filed under VARIOUS ORTHOPAEDIC AND TRAUMATOLOGY INSTRUMENTS.

Other devices from Brainlab Ltd

  • TraumaCad 2.5

    Class II

  • TraumaCad Neo 1.1

    Class II

  • TraumaCad Neo

    Class II

  • TraumaCad Neo (1.1)

    Class II

Properties

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