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ClearCorrect System Retainer

by ClearCorrect Operating LLC

Ref REF04

ClearCorrect System Retainer (REF04) is an orthodontic retainer (EU MDR Class IIa; FDA Class I; FDA product code KMY, Positioner, Tooth, Preformed) made by ClearCorrect Operating LLC, registered in EUDAMED on 28 May 2026 (Basic UDI-DI ++D865CCOrthoAppliance4G) with CE/MDR certificate 2270861CE01 valid until 1 May 2031 and listed in FDA GUDID since 25 Aug 2023 (UDI-DI D865REF04001), active as of 22 Oct 2026.

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

CE MDR

Valid until

1 May 2031

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier DEKRA Certification B.V.

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++D865CCOrthoAppliance4G Basic UDI-DI D865REF04001UDI-DIDate28 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD865REF04001 UDI-DI Date25 Aug 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI ++D865CCOrthoAppliance4G registered 28 May 2026 Active· +1 more in the status table
  • FDA GUDID UDI-DI D865REF04001 listed 25 Aug 2023 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2270861CE01 Active

    Quality management system EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    6 May 2026
    Expires
    1 May 2031

Timeline

4 dated events

  1. Listed FDA GUDID D865REF04001
  2. Certificate issued EUDAMED 2270861CE01
  3. Registered EUDAMED ++D865CCOrthoAppliance4G
  4. Certificate expires EUDAMED 2270861CE01

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  • Withdrawn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
ClearCorrect System Retainer EUDAMED
ClearCorrect System GUDID
Generic name
Orthodontic retainer
Device name
ClearCorrect Orthodontic Appliance
Model / Ref / Catalog
REF04, Retainer
Primary DI / UDI-DI
D865REF04001
Basic UDI-DI
++D865CCOrthoAppliance4G
FDA product code
KMY
EMDN code
Q010499 Orthodontic devices - other
GMDN term
Orthodontic retainer
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.5525
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
REF04
GUDID
Retainer
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Orthodontic retainer

Similar devices in this category

Other devices filed under ORTHODONTIC DEVICES - OTHER.

Other devices from ClearCorrect Operating LLC

Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)