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Ultrasonic Scaler Tips

by Guilin Veirun Medical Technology Co., Ltd. 2 variants

Ref /Model G1、G2、G3、G4、G5、G6、G8、G9、G12、G13、P1、P2L、P2R、P3、P4、P5、P7、P33、P13L、P13R、P15、P10、P11、P12、P12L、P12R、P16、P17、P18、IM1、IM2、IM3、IM4L、IM4R、E1、E2、E3、E4、E5、E8、E9、E14、E15、S-P1 etc.

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 Number06973042244234 UDI-DI Date23 Jun 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number697304224MDA000002FG Basic UDI-DI 06973042244234UDI-DIDate25 Jul 2025RegisteredStatusActive

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  • Withdrawn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

Generic Name
Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Model / Reference
G1、G2、G3、G4、G5、G6、G8、G9、G12、G13、P1、P2L、P2R、P3、P4、P5、P7、P33、P13L、P13R、P15、P10、P11、P12、P12L、P12R、P16、P17、P18、IM1、IM2、IM3、IM4L、IM4R、E1、E2、E3、E4、E5、E8、E9、E14、E15、S-P1 etc. EUDAMED
/ EUDAMED
P3 GUDID
5set/box GUDID
Primary DI / UDI-DI
06973042244234
Basic UDI-DI
697304224MDA000002FG
Direct Marketing DI
06973042244234
FDA Product Code
EMN
EMDN Code
L15900899 Dental equipment tips not included in other classes, reusable - other
GMDN Term
Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
872.4565
EU market of registration
Poland
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
CN-MF-000035683
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Guilin Veirun Medical Technology Co., Ltd.

See all devices from Guilin Veirun Medical Technology Co., Ltd. →

Properties

  • Reusable
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Single Use: No
  • Implantable: 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No