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CV-1 Manifold w/L-Cap

by GaleMed Corporation

Ref AB0125Model (H) Ventilation Circuit

Active European Union. Also listed in GUDID (US), not in commercial distribution.

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number04710810085550 UDI-DI Date5 Mar 2026ListedStatusListed GUDID: not in commercial distribution
European UnionCE/MDR EUDAMED Number471081008NNH57Q Basic UDI-DI 04710810085550UDI-DIDate31 Dec 2025RegisteredStatusActive

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  • Withdrawn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

Generic Name
Straight/elbow breathing circuit connector, single-use
Device Name
Manifold
Model / Ref / Catalog
(H) Ventilation Circuit, AB0125, 71053
Primary DI / UDI-DI
04710810085550
Basic UDI-DI
471081008NNH57Q
FDA Product Code
CAI
EMDN Code
R02010101 Breathing circuits, w/o water trap
GMDN Term
Straight/elbow breathing circuit connector, single-use
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
868.5240
EU market of registration
Netherlands
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
(H) Ventilation Circuit
AB0125
GUDID
71053
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
TW-MF-000022411
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from GaleMed Corporation

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Properties

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

Other properties (18)

  • Sterile: 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