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moorLDI2-BI

by Moor Instruments Ltd

Ref moorLDI2-BI

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-15060484490072 Basic UDI-DI 15060484490072UDI-DIDate23 Oct 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number15060484490072 UDI-DI Date8 Jul 2016ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
moorLDI2-BI EUDAMED
Moor Instruments Ltd GUDID
Generic Name
Cutaneous microcirculation laser Doppler imaging device
Device Name
moorLDI2-BI Laser Doppler Burns Imager and PC Software
Model / Reference
moorLDI2-BI
Primary DI / UDI-DI
15060484490072
Basic UDI-DI
B-15060484490072
510(k) Number
FDA Product Code
GEX, DPT
EMDN Code
Z110601 Laser imaging scanner
GMDN Term
Cutaneous microcirculation laser Doppler imaging device
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
878.4810, 870.2120
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
UK-MF-000042552
Authorised representative
Advena Limited MT-AR-000000234

Other devices from Moor Instruments Ltd

See all devices from Moor Instruments Ltd →

Properties

  • Measuring Function
  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (18)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No