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Air Motor & Air Handpiece & Coupling

by Saeshin Precision Co., Ltd. 8 variants

Ref ATN400

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

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08809260473003 UDI-DI Date21 May 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDD EUDAMED NumberB-08809260473003 Basic UDI-DI 08809260473003UDI-DIDate19 May 2023RegisteredStatusActive

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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
Air Motor & Air Handpiece & Coupling EUDAMED
TRAUS Air Dental Handpiece GUDID
Generic Name
Dental surgical power tool motorized handpiece/set, pneumatic
Model / Reference
ATN400 EUDAMED
TRAUS ATN400 #1 GUDID
Primary DI / UDI-DI
08809260473003
Basic UDI-DI
B-08809260473003
510(k) Number
FDA Product Code
EFB
EMDN Code
L1899 Electrosurgery instruments, reusable - other
GMDN Term
Dental surgical power tool motorized handpiece/set, pneumatic
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
872.4200
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
ATN400
GUDID
TRAUS ATN400 #1
Device ClassEUDAMED
Class IIa
GUDID
Class I

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

Other devices from Saeshin Precision Co., Ltd.

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

Properties

  • Reusable
  • Prescription Use
  • Serial Number

Other properties (19)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No