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Check-Flo G06002

by Cook Incorporated

Ref CFM-100

Check-Flo G06002 (CFM-100) is a haemostasis valve (EU MDD Class I; FDA Class II; FDA product code DTL, Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass) made by Cook Incorporated, registered in EUDAMED on 4 Aug 2026 (Basic UDI-DI B-00827002060029) and listed in FDA GUDID since 22 Aug 2017 (UDI-DI 00827002060029), active as of 25 Oct 2026.

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

CE MDD

Valid until

No date given

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

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00827002060029 Basic UDI-DI 00827002060029UDI-DIDate4 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00827002060029 UDI-DI Date22 Aug 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00827002060029 registered 4 Aug 2026 Active
  • FDA GUDID UDI-DI 00827002060029 listed 22 Aug 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00827002060029
  2. Registered EUDAMED B-00827002060029

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  • Withdrawn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
Check-Flo® EUDAMED
Check-Flo GUDID
Generic name
Haemostasis valve
Model / Ref / Catalog
CFM-100, G06002
Primary DI / UDI-DI
00827002060029
Basic UDI-DI
B-00827002060029
FDA product code
DTL
EMDN code
A070199 Adapters and connectors - other
GMDN term
Haemostasis valve
Device class
Class I EUDAMED
Class II GUDID
Regulation number
870.4290
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
CFM-100
GUDID
G06002
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Haemostasis valve

Similar devices in this category

Other devices filed under ADAPTERS AND CONNECTORS - OTHER.

Other devices from Cook Incorporated

See all devices from Cook Incorporated →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (16, all answered No)