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Surgical Instrument Ctwhe 50E

by S.I.N. - Sistema DE Implante Nacional S.A.

Ref CTWHE 50EModel DRIVER WITHOUT DLC

Surgical Instrument Ctwhe 50E is a device classified as Class IIa in the EU and Class II in the US made by S.I.N. - Sistema DE Implante Nacional S.A., registered in EUDAMED on 30 May 2026 (Basic UDI-DI 999520000011JK), cleared under FDA 510(k) K201688 on 21 Oct 2020 and listed in FDA GUDID since 25 Mar 2021 (UDI-DI 07899995298423), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K201688

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number999520000011JK Basic UDI-DI 07899995298423UDI-DIDate30 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07899995298423 UDI-DI Date25 Mar 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK201688 Date21 Oct 2020DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 999520000011JK registered 30 May 2026 Active
  • FDA 510(k) K201688 decided 21 Oct 2020 Active
  • FDA GUDID UDI-DI 07899995298423 listed 25 Mar 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K201688
  2. Listed FDA GUDID 07899995298423
  3. Registered EUDAMED 999520000011JK

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Driver Handpiece He H5.0 Nar. EUDAMED
Surgical Instrument GUDID
Generic name
Surgical screwdriver, single-use, non-sterile
Device name
Driver
Model / Ref / Catalog
CTWHE 50E, DRIVER WITHOUT DLC
Primary DI / UDI-DI
07899995298423
Basic UDI-DI
999520000011JK
510(k) Number
FDA product code
KCT
EMDN code
L159099 Odontostomatology instruments, reusable - other
GMDN term
Surgical screwdriver, single-use, non-sterile
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
880.6850
EU registration type
Standard device
EU market of registration
Portugal
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Surgical screwdriver, single-use, non-sterile

Cleared under the same submission (K201688)

and 8 more cleared under K201688

Other devices from S.I.N. - Sistema DE Implante Nacional S.A.

See all devices from S.I.N. - Sistema DE Implante Nacional S.A. →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (19, all answered No)