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Aura

by Kirwan Surgical Products LLC 270 variants

Ref 11-1403AU

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
European UnionCE/MDD EUDAMED NumberB-00841019102701 Basic UDI-DI 00841019102701UDI-DIDate27 May 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number00841019102701 UDI-DI Date9 May 2016ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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
Aura EUDAMED
Kirwan GUDID
Generic Name
Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
Device Name
Non-Stick Bipolar Coagulation Forceps 7 1/2 (19.1cm) Gerald Bayonet, Insulated, 1.0mm tip
Model / Reference
11-1403AU
Primary DI / UDI-DI
00841019102701
Basic UDI-DI
B-00841019102701
510(k) Number
FDA Product Code
GEI
EMDN Code
L180401 Open electrosurgery forceps, reusable
GMDN Term
Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
878.4400
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Length — 7.5 Inch

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000008222
Authorised representative
MPS Medical Product Service GmbH DE-AR-000005009

Related devices

Category: Endoscopic electrosurgical handpiece/electrode, bipolar, reusable

Other devices from Kirwan Surgical Products LLC

See all devices from Kirwan Surgical Products LLC →

Properties

  • Reusable
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (18)

  • 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
  • Serial Number: No
  • Expiration Date: No