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HYGENIC Boxing wax, Extra Fine, 450 g

by Coltene/Whaledent Inc. EUDAMEDGUDID

Active European Union

Ref H00816

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++D661039KU Basic UDI-DIDate27 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD661H008160 UDI-DIDate11 Feb 2019ListedStatusListed 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  • Withdrawn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

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
HYGENIC Boxing wax, Extra Fine, 450 g EUDAMED
Hygenic GUDID
Generic Name
Dental base plate
Device Name
HYGENIC Waxes
Model / Reference
H00816
Primary DI / UDI-DI
D661H008160
Basic UDI-DI
++D661039KU
FDA Product Code
EGD
EMDN Code
Q01020203 Occlusal waxes
GMDN Term
Dental base plate
Device Class
Class I
Regulation Number
872.6890
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
US-MF-000015761
Authorised representative
Coltène/Whaledent GmbH + Co. KG DE-AR-000005719

Other devices from Coltene/Whaledent Inc.

See all devices from Coltene/Whaledent 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