Skip to content

Panthera D-SAD Classic Duo 1

by Panthera Dentaire Inc EUDAMEDGUDID

Active European Union

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number7540204D-SADKL Basic UDI-DIDate11 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07540204000275 UDI-DIDate28 Nov 2025ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

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

0 recalls · FDA

No FDA recalls on record, checked 24 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Classic Duo EUDAMED
Panthera D-SAD Classic Duo GUDID
Generic Name
Mandible-repositioning sleep-disordered breathing orthosis
Model / Reference
1
Primary DI / UDI-DI
07540204000275
Basic UDI-DI
7540204D-SADKL
510(k) Number
FDA Product Code
LRK
EMDN Code
Q03010299 Antisnoring and obstructive sleep apnoea devices - other
GMDN Term
Mandible-repositioning sleep-disordered breathing orthosis
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
872.5570
Market of Registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
N/A
GUDID
1
Device ClassEUDAMED
Class I
GUDID
Class II

Related devices

Cleared under the same submission (K143244)

Other devices from Panthera Dentaire Inc

See all devices from Panthera Dentaire Inc →

Properties

  • Prescription Use
  • Lot / Batch 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
  • Serial Number: No
  • Expiration Date: No