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Reverse Drill

by OSSTEM IMPLANT Co., Ltd. 3 variants

Part of a family of 15 devices: see the family page

Ref TSRRDML

Reverse Drill (TSRRDML) is a Class IIa device made by Osstem Implant Co., Ltd, registered in EUDAMED on 10 Feb 2026 (Basic UDI-DI 88000406DRILL1EU), active as of 23 Oct 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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number88000406DRILL1EU Basic UDI-DI 08800342270640UDI-DIDate10 Feb 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Surgical Drill System (Single use)
Model / reference
TSRRDML
Primary DI / UDI-DI
08800342270640
Basic UDI-DI
88000406DRILL1EU
EMDN code
Q010599 Dental instruments, single-use - other
Device class
Class IIa
EU registration type
Standard device
EU market of registration
Czechia

Manufacturer details

EUDAMED SRN
KR-MF-000020006
Authorised representative
Obelis s.a. BE-AR-000000106

Similar devices in this category

Other devices filed under DENTAL INSTRUMENTS, SINGLE-USE - OTHER.

Other devices from Osstem Implant Co., Ltd

See all devices from Osstem Implant Co., Ltd →

Properties

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