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IB Lab LAMA

by IB Lab GmbH 2 variants

Ref V2.0

IB Lab LAMA (V2.0) is a medical device (EU MDR Class IIa) made by IB Lab GmbH, registered in EUDAMED on 26 Jun 2025 (Basic UDI-DI 912010573IBLABLAMAPE) and cleared under FDA 510(k) K223646 on 16 Jun 2023, active as of 24 Oct 2026.

Active European Union and United States

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) K223646↗

FDA record

Trust

Unverified

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

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number912010573IBLABLAMAPE Basic UDI-DI 09120105730747UDI-DIDate26 Jun 2025RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK223646 Date16 Jun 2023IssuedStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 912010573IBLABLAMAPE registered 26 Jun 2025 Active
  • FDA 510(k) K223646 decided 16 Jun 2023 Active

Timeline

2 dated events

  1. Cleared FDA 510(k) K223646
  2. Registered EUDAMED 912010573IBLABLAMAPE

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  • Withdrawn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)

Model / reference
V2.0
Primary DI / UDI-DI
09120105730747
Basic UDI-DI
912010573IBLABLAMAPE
Direct marketing DI
09120105730747
EMDN code
Z11069092 Various digital bioimaging management instruments - medical device software
Device class
Class IIa
Special device type
Software
EU registration type
Standard device
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
AT-MF-000006554

Similar devices in this category

Other devices filed under VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE.

Other devices from IB Lab GmbH

See all devices from IB Lab GmbH →

Properties

  • Measuring function
Other properties (13, all answered No)