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Leaseir MHR Xcell

by Leaseir Technologies, S.L.U.

Ref MHR 110-b

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

1 closed

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
United StatesGUDID listing GUDID Number08437019546014 UDI-DI Date21 Feb 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number8437019546XcellSU Basic UDI-DI 08437019546014UDI-DIDate5 Jun 2023RegisteredStatusActive EUDAMED: not on the EU market

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

1 recall · FDA

    • Completed Z-1130-2026 FDA Class II initiated 15 Dec 2025

    The console label for affected devices is missing the "DANGER" symbol.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Leaseir Technologies SLU
Generic Name
Dermatological diode laser system
Model / Reference
MHR 110-b EUDAMED
Leaseir MHR Xcell GUDID
Primary DI / UDI-DI
08437019546014
Basic UDI-DI
8437019546XcellSU
Direct Marketing DI
08437019546014
510(k) Number
FDA Product Code
GEX
EMDN Code
Z12011016 Diode surgical laser
GMDN Term
Dermatological diode laser system
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
878.4810
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
MHR 110-b
GUDID
Leaseir MHR Xcell
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
ES-MF-000002995

Other devices from Leaseir Technologies, S.L.U.

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: 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