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LM-Activator2 High Long 65 Narrow Reinforced

by LM-Instruments Oy

Ref 94265HLNR

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE MDR, withdrawn

Ended

Withdrawn

Date not published (CE MDR)

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number6438311ROA10UU Basic UDI-DI 06438311223780UDI-DIDate5 May 2022RegisteredStatusWithdrawn No longer placed on the EU market
United StatesGUDID listing GUDID Number06438311223780 UDI-DI Date31 Aug 2020ListedStatusListed GUDID: not in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

2 jurisdictions

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  • Withdrawn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  • European Union CE/MDR Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
LM-Activator2 High Long 65 Narrow Reinforced EUDAMED
LMDental GUDID
Generic Name
Orthodontic retainer
Device Name
Removable orthodontic appliance
Model / Reference
94265HLNR
Primary DI / UDI-DI
06438311223780
Basic UDI-DI
6438311ROA10UU
FDA Product Code
KMY
EMDN Code
Q010499 Orthodontic devices - other
GMDN Term
Orthodontic retainer
Device Class
Class I
Regulation Number
872.5525
EU market of registration
Finland
GUDID distribution status
Not in Commercial Distribution

Manufacturer details

EUDAMED SRN
FI-MF-000006705

Other devices from LM-Instruments Oy

See all devices from LM-Instruments Oy →

Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (19)

  • Sterile: 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
  • Serial Number: No
  • Expiration Date: No