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FISSO Respiratory Circuit Holder

by Baitella AG Switzerland EUDAMEDGUDID

Ref 3670.40Model 2628.xx 3628.xx, 3640.xx 3511.xx, 3590.xx 3670.xx, 3690.xx Product code BZOEMDN V0880

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number76401525727IPSa65767V Basic UDI-DIDate3 Feb 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number07640152572944 UDI-DIDate30 Oct 2021ListedStatusIn 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 Respiratory Circuit Holder EUDAMED
Fisso GUDID
Generic Name
Breathing circuit tube holder
Device Name
Anesthesia
Model / Reference
2628.xx 3628.xx, 3640.xx 3511.xx, 3590.xx 3670.xx, 3690.xx, 3670.40
Primary DI / UDI-DI
07640152572944
Basic UDI-DI
76401525727IPSa65767V
Direct Marketing DI
07640152572944
FDA Product Code
BZO
EMDN Code
V0880 Medical support equipment - accessories
GMDN Term
Breathing circuit tube holder
Device Class
Class I
Regulation Number
868.5975
Market of Registration
Germany
Commercial Distribution
In Commercial Distribution

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 (2)

  • EUDAMED 0cdee6c4-a757-4b27-a80f-a9b0de785656 61 fields · synced 22 Oct 2026
  • FDA UDI d31a2de5-3fb1-4fe2-b11e-30c6dd934418 33 fields · synced 30 May 2026