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Rk-97 L 30221000

by W&H Dentalwerk Burmoos

Ref 30221000

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
European UnionCE/MDR EUDAMED Number++J021RP0001Q8 Basic UDI-DI +J021302210001UDI-DIDate8 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number+J021302210001 UDI-DI Date10 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  • Withdrawn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
Rk-97 L
Generic Name
Dental surgical power tool motorized handpiece/set, pneumatic
Device Name
Turbines R&P
Model / Reference
30221000
Primary DI / UDI-DI
+J021302210001 EUDAMED
J021302210001 GUDID
Basic UDI-DI
++J021RP0001Q8
Direct Marketing DI
+J021302210000
FDA Product Code
EFB
EMDN Code
Z12110180 Instruments for dental treatment units - hardware accessories
GMDN Term
Dental surgical power tool motorized handpiece/set, pneumatic
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
872.4200
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
+J021302210001
GUDID
J021302210001
Device ClassEUDAMED
Class IIa
GUDID
Class I

Related devices

Category: Dental surgical power tool motorized handpiece/set, pneumatic

Other devices from W&H Dentalwerk Burmoos

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Properties

  • Reusable
  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (20)

  • 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