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Breathing Circuit

by Create Biotech Co., Ltd. 5 variants

Ref 010-001-1065

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

CE MDD

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number04719874956554 UDI-DI Date16 Jul 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDD EUDAMED NumberB-04719874956554 Basic UDI-DI 04719874956554UDI-DIDate15 Jun 2026RegisteredStatusActive

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  • Withdrawn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/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Create Biotech
Generic Name
Ventilator breathing circuit, single-use
Device Name
Breathing Circuit
Model / Reference
010-001-1065
Primary DI / UDI-DI
04719874956554
Basic UDI-DI
B-04719874956554
FDA Product Code
CAI
EMDN Code
R02010101 Breathing circuits, w/o water trap
GMDN Term
Ventilator breathing circuit, single-use
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
868.5240
EU market of registration
Greece
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
TW-MF-000021770
Authorised representative
JOUMED TECHNOLOGY OÜ EE-AR-000012526

Other devices from Create Biotech Co., Ltd.

See all devices from Create Biotech Co., Ltd. →

Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (16)

  • Sterile: No
  • Implantable: No
  • Reusable: 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
  • Serial Number: No