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ZA-55 M Scaler without light 10035503

by W&H Dentalwerk Burmoos

Ref 10035503

Active European Union. Also listed in GUDID (US), not in commercial distribution.

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
European UnionCE/MDR EUDAMED Number++J021P0008QF Basic UDI-DI +J021100355031UDI-DIDate23 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number+J021100355031 UDI-DI Date31 Aug 2018ListedStatusListed GUDID: not 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  • Withdrawn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
Za-55 M EUDAMED
ZA-55 M Scaler without light GUDID
Generic Name
Pneumatic dental scaling/debridement system
Device Name
Air Scaler Handpieces Prophy&Paro, R&P, Endo, OCI
Model / Reference
10035503
Primary DI / UDI-DI
+J021100355031 EUDAMED
J021100355031 GUDID
Basic UDI-DI
++J021P0008QF
Direct Marketing DI
+J021100355030
FDA Product Code
EFB
EMDN Code
Z12119001 Tartar ablators
GMDN Term
Pneumatic dental scaling/debridement system
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
872.4200
EU market of registration
Austria
GUDID distribution status
Not in Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
+J021100355031
GUDID
J021100355031
Device ClassEUDAMED
Class IIa
GUDID
Class I

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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