Skip to content

TechLive

by DeepHealth, Inc.

Ref V.1.x.yModel v1.x.y

TechLive (V.1.x.y) is a device classified as Class I in the EU and Class II in the US made by Deephealth, registered in EUDAMED on 10 Apr 2026 (Basic UDI-DI 08600051440TL1LB), cleared under FDA 510(k) K243703 on 5 Jun 2025 and listed in FDA GUDID since 22 Apr 2026 (UDI-DI 00860005144044), 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) K243703

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00860005144044 UDI-DI Date22 Apr 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number08600051440TL1LB Basic UDI-DI 00860005144044UDI-DIDate10 Apr 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK243703 Date5 Jun 2025DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08600051440TL1LB registered 10 Apr 2026 Active
  • FDA 510(k) K243703 decided 5 Jun 2025 Active
  • FDA GUDID UDI-DI 00860005144044 listed 22 Apr 2026 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K243703
  2. Registered EUDAMED 08600051440TL1LB
  3. Listed FDA GUDID 00860005144044

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  • Withdrawn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
Multidisciplinary medical image management software
Model / reference
v1.x.y EUDAMED
V.1.x.y EUDAMED
1.2.1 GUDID
Primary DI / UDI-DI
00860005144044
Basic UDI-DI
08600051440TL1LB
510(k) Number
FDA product code
LLZ
EMDN code
Z119092 Various bioimaging and radiotherapy instruments - medical device software
GMDN term
Multidisciplinary medical image management software
Device class
Class I 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
v1.x.y
V.1.x.y
GUDID
1.2.1
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
US-MF-000051664
Authorised representative
MedEnvoy Global BV NL-AR-000024028

Similar devices in this category

Other devices filed under VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - MEDICAL DEVICE SOFTWARE.

Other devices from Deephealth

See all devices from Deephealth →

Properties

  • Convenience kit
  • Lot / batch number
Other properties (23, all answered No)