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Resin Keeper

by Cosmedent, Inc.

Ref 901101

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 linked in EUDAMED

A group certificate may exist

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 Number++D779RESINKEEPER3S Basic UDI-DI D7799011010UDI-DIDate30 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD7799011010 UDI-DI Date17 Feb 2020ListedStatusListed GUDID: in commercial distribution

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.

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  • Withdrawn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
ResinKeeper
Generic Name
Dental material mixing surface, chairside, reusable
Device Name
Resin Keeper
Model / Reference
901101
Primary DI / UDI-DI
D7799011010 EUDAMED
D77990110114 GUDID
Basic UDI-DI
++D779RESINKEEPER3S
FDA Product Code
FSM
EMDN Code
Q010199 Conservative dentistry and endodontics devices - other
GMDN Term
Dental material mixing surface, chairside, reusable
Device Class
Class I
Regulation Number
878.4800
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
D7799011010
GUDID
D77990110114

Manufacturer details

EUDAMED SRN
US-MF-000045496
Authorised representative
SAS Exclusivas Dentales S.L. ES-AR-000045423

Other devices from Cosmedent, Inc.

See all devices from Cosmedent, Inc. →

Properties

  • Premarket Exempt

Other properties (23)

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