Skip to content

ClearCorrect System Aligner (Single-layer)

by ClearCorrect Operating LLC

Ref REF05

ClearCorrect System Aligner (Single-layer) (REF-05) is an orthodontic progressive aligner (EU MDR Class IIa; FDA Class II; FDA product code NXC, Aligner, Sequential) 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 D865REF05001), 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 D865REF05001UDI-DIDate28 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD865REF05001 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 D865REF05001 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 D865REF05001
  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  • Withdrawn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 Aligner (Single Layer) EUDAMED
ClearCorrect System GUDID
Generic name
Orthodontic progressive aligner
Device name
ClearCorrect Orthodontic Appliance
Model / Ref / Catalog
REF05 EUDAMED
Aligner (Single-layer) GUDID
REF-05 GUDID
Primary DI / UDI-DI
D865REF05001
Basic UDI-DI
++D865CCOrthoAppliance4G
FDA product code
NXC
EMDN code
Q010499 Orthodontic devices - other
GMDN term
Orthodontic progressive aligner
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.5470
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
REF05
GUDID
Aligner (Single-layer)
Device classEUDAMED
Class IIa
GUDID
Class II

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

Related devices

Category: Orthodontic progressive aligner

Similar devices in this category

Other devices filed under ORTHODONTIC DEVICES - OTHER.

Other devices from ClearCorrect Operating LLC

Properties

  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (20, all answered No)