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Power Stick M5/0 8995500001

by Richard Wolf GmbH

Ref 8995500001Model 10000201121

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

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04055207036693 Basic UDI-DI 04055207036693UDI-DIDate4 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04055207036693 UDI-DI Date18 Dec 2025ListedStatusListed 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  • Withdrawn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/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Power Stick M5/0
Generic Name
Surgical power tool system control unit, line-powered
Device Name
Motorized devices
Model / Ref / Catalog
8995500001, 10000201121
Description
MOTOR HANDPIECE MAX. 16000RPM with fixed connection cable, for use with rotation tools, control by footswitch, reusable
Primary DI / UDI-DI
04055207036693
Basic UDI-DI
B-04055207036693
FDA Product Code
GEY
EMDN Code
Z12020280 Motorised instruments for endoscopic surgery - hardware accessories
GMDN Term
Surgical power tool system control unit, line-powered
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
878.4820
EU market of registration
Germany
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 I

Other devices from Richard Wolf GmbH

See all devices from Richard Wolf GmbH →

Properties

  • Premarket Exempt
  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No