Skip to content

BISSWÄLLE ORANGE (mittel)

by gebdi DENTAL-PRODUCTS GmbH

Ref 82900

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 Number42518579BissregWallH8 Basic UDI-DI +EGEB82900UDI-DIDate12 Oct 2021RegisteredStatusActive
United StatesGUDID listing GUDID Number+EGEB82900 UDI-DI Date4 Aug 2017ListedStatusListed 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  • Withdrawn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

Generic Name
Denture clasp, metal, custom-made
Device Name
Bisswälle
Model / Reference
82900
Primary DI / UDI-DI
+EGEB82900 EUDAMED
EGEB82900 GUDID
Basic UDI-DI
42518579BissregWallH8
FDA Product Code
EGD
EMDN Code
Q01020199 Dental impression materials - other
GMDN Term
Denture clasp, metal, custom-made
Device Class
Class I
Regulation Number
872.6890
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
+EGEB82900
GUDID
EGEB82900

Manufacturer details

EUDAMED SRN
DE-MF-000005566

Related devices

Category: Silicone dental impression material

Other devices from Gebdi Dental-Products GmbH

See all devices from Gebdi Dental-Products GmbH →

Properties

  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (20)

  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No