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My LM-Activator 55 Low Long

by LM-Instruments Oy

Ref 94455LL

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

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
United StatesGUDID listing GUDID Number06438311231464 UDI-DI Date23 May 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number6438311ROA10UU Basic UDI-DI 06438311231464UDI-DIDate5 May 2022RegisteredStatusActive

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  • Withdrawn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 Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
My LM-Activator 55 Low Long EUDAMED
LMDental GUDID
Generic Name
Orthodontic retainer
Device Name
Removable orthodontic appliance
Model / Ref / Catalog
94455LL
Primary DI / UDI-DI
06438311231464
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
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