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S-12

by W & H Dentalwerk Bürmoos GmbH

Ref 30061000

Active European Union. Also listed in GUDID (US).

CE MDR CE MDD

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 NumberB-J021300610001 Basic UDI-DI Date23 Jan 2024RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-J021300610001 Basic UDI-DI Date23 Jan 2024RegisteredStatusActive
United StatesGUDID listing GUDID NumberJ021300610001 UDI-DI Date15 Feb 2017ListedStatusListed 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  • Withdrawn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, CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
S-12 EUDAMED
S-12 surgical handpiece 1:2 GUDID
Generic Name
Dental surgical power tool motorized handpiece/set, electric
Device Name
Surgical Handpieces S-12
Handpieces OCI
Model / Reference
30061000
Primary DI / UDI-DI
J021300610001, +J021300610001
Basic UDI-DI
B-J021300610001, ++J021S0004R8
Direct Marketing DI
+J021300610000
FDA Product Code
KMW
EMDN Code
Z12119099 Various dental stomatology instruments - other
GMDN Term
Dental surgical power tool motorized handpiece/set, electric
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
872.4120
EU market of registration
Austria
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 II

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

  • Reusable
  • Prescription Use
  • Serial Number

Other properties (21)

  • 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
  • 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