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Brite Shield 9011911

by Premier Dental Products Company

Ref 9011911

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number00348783BriteShieldTX Basic UDI-DI 00348783003802UDI-DIDate1 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00348783003802 UDI-DI Date29 Jun 2022ListedStatusListed 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  • Withdrawn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
Brite Shield Sample INTL w/Illustration Card EUDAMED
Brite Shield GUDID
Generic Name
Medical device disinfection agent
Model / Reference
9011911
Primary DI / UDI-DI
00348783003802
Basic UDI-DI
00348783BriteShieldTX
FDA Product Code
FLG
EMDN Code
D0801 Enzymatic detergents for medical devices
GMDN Term
Medical device disinfection agent
Device Class
Class I
Regulation Number
880.6150
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Related devices

Category: Medical device disinfection agent

Other devices from Premier Dental Products Company

See all devices from Premier Dental Products Company →

Properties

  • Over-the-Counter
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (20)

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