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Blugloo Unidose Kit

by Ormco Corporation

Ref 740-0275

Active European Union. Also listed in GUDID (US).

CE MDD

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/MDD EUDAMED NumberB-00889989075373 Basic UDI-DI 00889989075373UDI-DIDate18 Sep 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00889989075373 UDI-DI Date8 Sep 2016ListedStatusListed 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  • Withdrawn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/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
BluGloo
Generic Name
Orthodontic bracket adhesive
Device Name
Blugloo Unidose Kit
Model / Reference
740-0275
Primary DI / UDI-DI
00889989075373 EUDAMED
00889989080162 GUDID
Basic UDI-DI
B-00889989075373
FDA Product Code
DYH
EMDN Code
Q01010104 Dental bonding agents
GMDN Term
Orthodontic bracket adhesive
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
872.3750
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Size
Weight — 4 Gram

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00889989075373
GUDID
00889989080162
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000038085
Authorised representative
KERR ITALIA SRL IT-AR-000007600

Related devices

Category: Dentine bonding agent/set

Other devices from Ormco Corporation

See all devices from Ormco Corporation →

Properties

  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • 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
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No