Skip to content

FISSO Instrument Holder

by Baitella AG Switzerland EUDAMEDGUDID

Ref 3840.40, 3840.55, 3840.41-4524Model 3828.xx, 3840.xx, 3855.xx 4840.xx, 4850.xx 5850.xx, 5870.xx 5.75x Product code FWZEMDN V0880

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number76401525706OPS7879JG Basic UDI-DIDate3 Feb 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number07640152572685 UDI-DIDate1 Jul 2019ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Trade Name
FISSO Instrument Holder EUDAMED
Fisso GUDID
Generic Name
Surgical instrument assist arm system, manually-adjusted
Device Name
Surgery
Model / Reference
3828.xx, 3840.xx, 3855.xx 4840.xx, 4850.xx 5850.xx, 5870.xx 5.75x, 3840.40, 3840.55, 3840.41-4524
Primary DI / UDI-DI
07640152572685, 07640152573194, 07640152573125
Basic UDI-DI
76401525706OPS7879JG
Direct Marketing DI
07640152572685
07640152573194
07640152573125
FDA Product Code
FWZ
EMDN Code
V0880 Medical support equipment - accessories
GMDN Term
Surgical instrument assist arm system, manually-adjusted
Device Class
Class I
Regulation Number
878.4950
Market of Registration
Germany
Commercial Distribution
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Manufacturer details

EUDAMED SRN
CH-MF-000017307
Authorised representative
Baitella GmbH DE-AR-000014387

Other devices from Baitella AG

See all devices from Baitella AG →

Properties & raw data

Show properties, registry sources and raw records
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date
Other properties (20)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No

Sources (4)

  • EUDAMED 9157c173-3d6c-47c7-81e1-50884deae9a3 61 fields · synced 22 Oct 2026
  • EUDAMED 07640152573194|76401525706OPS7879JG 61 fields · synced 19 May 2026
  • EUDAMED 07640152573125|76401525706OPS7879JG 61 fields · synced 19 May 2026
  • FDA UDI 7966494d-24a9-46eb-838b-38595486fe47 34 fields · synced 30 May 2026