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Micro Applicator Tips

by Premium Plus (Dongguan) Limited 6 variants

Ref B922B

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, self-declared

Class I: no certifier involved

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 Number+D125B922B2 UDI-DI Date21 May 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number++D125APPLICATORK8 Basic UDI-DI +D125B922B2UDI-DIDate7 Jul 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

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  • Withdrawn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
Micro Applicator Tips EUDAMED
Premium Plus GUDID
Generic Name
Dental material application tool, single-use
Device Name
Applicators
Model / Reference
B922B
Primary DI / UDI-DI
+D125B922B2 EUDAMED
D125B922B2 GUDID
Basic UDI-DI
++D125APPLICATORK8
Unit of Use DI
2
FDA Product Code
KXR
EMDN Code
Q019006 Dental material application tips and brushes, single-use
GMDN Term
Dental material application tool, single-use
Device Class
Class I
Regulation Number
872.3140
EU market of registration
Poland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
+D125B922B2
GUDID
D125B922B2

Manufacturer details

EUDAMED SRN
CN-MF-000038259
Authorised representative
Premium Plus Poland sp. z o.o. PL-AR-000030110

Other devices from Premium Plus (Dongguan) Limited

See all devices from Premium Plus (Dongguan) Limited →

Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • 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
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No