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Implant driver, ratchet, HE.

by Roott AG

Ref ITHE

Implant driver, ratchet, HE. (ITHE) is a Class I device made by Roott AG, registered in EUDAMED on 22 Oct 2026 (Basic UDI-DI 76300538ImplantdriverHE7S), active as of 7 Nov 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number76300538ImplantdriverHE7S Basic UDI-DI Date22 Oct 2026RegisteredStatusActive

Official records

  • EUDAMED public site Basic UDI-DI 76300538ImplantdriverHE7S — open Devices and search for it

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Implant driver
Model / reference
ITHE
Primary DI / UDI-DI
37630053805631, 17630053805637
Basic UDI-DI
76300538ImplantdriverHE7S
Unit of use DI
07630053805630
EMDN code
L99 Surgical instruments, reusable - other
Device class
Class I
EU registration type
Standard device
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
CH-MF-000019071
Authorised representative
Roott UAB LT-AR-000002509

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Properties

  • Sterilise before use
Other properties (13, all answered No)