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BOARD DMX3 M Bornier

by Bien-Air Dental SA

Ref 1502122-001Model Electric Micromtors

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
United StatesGUDID listing GUDID NumberJ00715021220011 UDI-DI Date24 Feb 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number++J007EMOT0001UH Basic UDI-DI J00715021220011UDI-DIDate5 Mar 2024RegisteredStatusActive

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  • Withdrawn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
Surgical power tool system control unit, line-powered
Device Name
Electric Micromtors
Model / Reference
Electric Micromtors, 1502122-001
Primary DI / UDI-DI
J00715021220011
Basic UDI-DI
++J007EMOT0001UH
Direct Marketing DI
J00715021220011
FDA Product Code
EIA
EMDN Code
Z12110199 Instruments for dental treatment units - other
GMDN Term
Surgical power tool system control unit, line-powered
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
872.6640
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
CH-MF-000014661
Authorised representative
Bien-Air Europe Sàrl FR-AR-000011942

Other devices from Bien-Air Dental SA

See all devices from Bien-Air Dental SA →

Properties

  • Prescription Use
  • Serial Number

Other properties (22)

  • 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
  • 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