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Enamel Plus Stain & Instruments TPENMS

by Micerium SpA

Ref TPENMS

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 NumberEMICTPENMS1 UDI-DI Date5 May 2023ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number++EMICFAM1DVD Basic UDI-DI EMICTPENMS1UDI-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  • Withdrawn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
Enamel Plus Stain & Instruments
Generic Name
Dental material application tool, reusable
Device Name
Ena / Enamel Plus
Model / Ref / Catalog
TPENMS
Description
Enamel Plus Stain and Instruments - 5 Spare blue rubber brush tips sterilizable - 190/180 degrees titl metal handle for compiste modelling
Primary DI / UDI-DI
EMICTPENMS1
Basic UDI-DI
++EMICFAM1DVD
FDA Product Code
EJB
EMDN Code
Q010199 Conservative dentistry and endodontics devices - other
GMDN Term
Dental material application tool, reusable
Device Class
Class I
Regulation Number
872.4565
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Other devices from Micerium SpA

See all devices from Micerium SpA →

Properties

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

Other properties (19)

  • 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
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No