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Assistina 301 plus

by W & H Dentalwerk Bürmoos GmbH 2 variants

Ref 00030140Model 00030135

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++J021Assist3014U Basic UDI-DI J021000301401UDI-DIDate17 Jan 2022RegisteredStatusActive
United StatesGUDID listing GUDID NumberJ021000301401 UDI-DI Date8 Sep 2019ListedStatusListed 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  • Withdrawn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/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Assistina 301 plus EUDAMED
Assistina 301+ GUDID
Generic Name
Dental handpiece maintenance unit
Model / Reference
00030135, 00030140
Primary DI / UDI-DI
J021000301401
Basic UDI-DI
++J021Assist3014U
Direct Marketing DI
+J021000301400
FDA Product Code
EFB
EMDN Code
Z12119006 Dental cleaning/washing handpiece equipments
GMDN Term
Dental handpiece maintenance unit
Device Class
Class I
Regulation Number
872.4200
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
AT-MF-000001590

Other devices from W & H Dentalwerk Bürmoos GmbH

See all devices from W & H Dentalwerk Bürmoos GmbH →

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (21)

  • 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