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Ultrasonic Scaler MS-1/MS-1 Dual

by Rolence Enterprise Inc. EUDAMEDGUDID

Active European Union

Ref 1214Model MS-1

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04713909450550 Basic UDI-DIDate14 Jul 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number04713909450550 UDI-DIDate23 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

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.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Ultrasonic Scaler MS-1/MS-1 Dual EUDAMED
ELiTEDENT GUDID
Generic Name
Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Model / Reference
MS-1, 1214
Primary DI / UDI-DI
04713909450550
Basic UDI-DI
B-04713909450550
510(k) Number
FDA Product Code
ELC
EMDN Code
Z12011302 Ultrasonic cleaning equipment
GMDN Term
Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
872.4850
Market of Registration
Ireland
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
TW-MF-000024483
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Rolence Enterprise Inc.

See all devices from Rolence Enterprise Inc. →

Properties

  • Serial Number

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: 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
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No