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Ena Brush COSPEN11

by Micerium SpA

Ref COSPEN11

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
United StatesGUDID listing GUDID NumberEMICCOSPEN111 UDI-DI Date6 Aug 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number++EMICFAM1DVD Basic UDI-DI EMICCOSPEN111UDI-DIDate8 Feb 2022RegisteredStatusActive

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  • Withdrawn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
Ena Brush
Generic Name
Dental restoration carver, resin
Device Name
Ena / Enamel Plus
Model / Ref / Catalog
COSPEN11
Primary DI / UDI-DI
EMICCOSPEN111
Basic UDI-DI
++EMICFAM1DVD
FDA Product Code
EJB
EMDN Code
Q010199 Conservative dentistry and endodontics devices - other
GMDN Term
Dental restoration carver, resin
Device Class
Class I
Regulation Number
872.4565
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 0.8 Millimeter

Other devices from Micerium SpA

See all devices from Micerium SpA →

Properties

  • Reprocessed
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: 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
  • Expiration Date: No