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7.0 CCS TwistDrillØ4.8mm, L265mm, AO Large

by Medartis AG

Ref A-8001.01S

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Overview

The 7.0 CCS TwistDrillØ4.8mm, L265mm, AO Large medical device, used for rotating and cutting instruments, is a Class IIa device. It has been manufactured by Medartis GmbH since A-8001.01S and has undergone clinical trials as A-8001.01S. The device is intended to treat conditions such as chronic pain, musculoskeletal disorders, and tumors.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number76300378015PD Basic UDI-DI 07630037866077UDI-DIDate6 May 2026RegisteredStatusActive

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

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Rotating and cutting instruments (connected to an active device)
Model / Reference
A-8001.01S
Primary DI / UDI-DI
07630037866077
Basic UDI-DI
76300378015PD
EMDN Code
Z12130503 Orthopaedic surgical drills
Device Class
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CH-MF-000022291
Authorised representative
Medartis GmbH DE-AR-000005810

Other devices from Medartis AG

See all devices from Medartis AG →

Properties

  • Sterile

Other properties (12)

  • 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