Skip to content

FISSO Anaesthetic Tube Holder

by Baitella AG 6 variants

Ref 3628.13-1747Model 2628.xx 3628.xx, 3640.xx 3511.xx, 3590.xx 3670.xx, 3690.xx

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

CE MDR

Valid until

Not listed

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

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 Number07640152573323 UDI-DI Date2 Feb 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number76401525727IPSa65767V Basic UDI-DI 07640152573323UDI-DIDate3 Feb 2022RegisteredStatusActive

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.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
FISSO Anaesthetic Tube 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, 3628.13-1747
Primary DI / UDI-DI
07640152573323
Basic UDI-DI
76401525727IPSa65767V
Direct Marketing DI
07640152573323
FDA Product Code
CAI
EMDN Code
V0880 Medical support equipment - accessories
GMDN Term
Breathing circuit tube holder
Device Class
Class I
Regulation Number
868.5240
EU market of registration
Germany
GUDID distribution status
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

  • 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