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Traus Series

by Saeshin Precision Co., Ltd. 13 variants

Ref SIP10

Traus Series (SIP10) is a device classified as Class IIa in the EU and Class I in the US made by Saeshin Precision Co., Ltd., registered in EUDAMED on 10 May 2023 (Basic UDI-DI B-08809260470736) and listed in FDA GUDID since 22 Jan 2020 (UDI-DI 08809260470736), active as of 22 Oct 2026.

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

CE MDD

Valid until

No date given

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

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08809260470736 Basic UDI-DI 08809260470736UDI-DIDate10 May 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number08809260470736 UDI-DI Date22 Jan 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08809260470736 registered 10 May 2023 Active
  • FDA GUDID UDI-DI 08809260470736 listed 22 Jan 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08809260470736
  2. Registered EUDAMED B-08809260470736

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  • Withdrawn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
Traus Series EUDAMED
Traus SIP10 GUDID
Generic name
Dental power tool system, line-powered
Model / reference
SIP10 EUDAMED
TRAUS SIP10 #4 GUDID
Description
20:1 , non-optic XIP10+FUS10+CRB26XX+MBP10SX
Primary DI / UDI-DI
08809260470736
Basic UDI-DI
B-08809260470736
FDA product code
EKY
EMDN code
L1899 Electrosurgery instruments, reusable - other
GMDN term
Dental power tool system, line-powered
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.4200
System or procedure pack
System which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
SIP10
GUDID
TRAUS SIP10 #4
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
KR-MF-000016345
Authorised representative
Meridius Medical Europe Limited IE-AR-000004258

Related devices

Category: Electrical-only medical device connection cable, reusable

Similar devices in this category

Other devices filed under ELECTROSURGERY INSTRUMENTS, REUSABLE - OTHER.

Other devices from Saeshin Precision Co., Ltd.

See all devices from Saeshin Precision Co., Ltd. →

Properties

  • Sterilise before use
  • Reusable
  • Serial number
Other properties (20, all answered No)