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Orthodontic Relief Wax

by Ortho Organizers, Inc. 6 variants

Ref 301-030C

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
European UnionCE/MDR EUDAMED Number0190707O2ReliefWaxVL Basic UDI-DI 00190707083861UDI-DIDate18 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00190707083861 UDI-DI Date13 Jul 2020ListedStatusListed GUDID: 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  • Withdrawn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 Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Orthodontic Relief Wax EUDAMED
Relief Wax GUDID
Generic Name
Orthodontic appliance relief material
Device Name
Intraoral Dental Wax
Model / Reference
301-030C
Primary DI / UDI-DI
00190707083861
Basic UDI-DI
0190707O2ReliefWaxVL
Unit of Use DI
10190707083868
FDA Product Code
EGD
EMDN Code
Q010499 Orthodontic devices - other
GMDN Term
Orthodontic appliance relief material
Device Class
Class I
Regulation Number
872.6890
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
US-MF-000010061
Authorised representative
mdi Europa GmbH DE-AR-000006218

Other devices from Ortho Organizers, Inc.

See all devices from Ortho Organizers, Inc. →

Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration 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
  • Manufacturing Date: No