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HEMO-NATE Needleless Filter Set

by Utah Medical Products, Inc.

Ref 4020005

HEMO-NATE Needleless Filter Set (4020005) is a device classified as Class IIa in the EU and Class II in the US made by Utah Medical Products, Inc., registered in EUDAMED on 10 Jun 2026 (Basic UDI-DI ++H671CE019IIADM), cleared under FDA 510(k) K781815 on 27 Feb 1979 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI H67140200050), active as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K781815

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++H671CE019IIADM Basic UDI-DI H67140200050UDI-DIDate10 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberH67140200050 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK781815 Date27 Feb 1979DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI ++H671CE019IIADM registered 10 Jun 2026 Active
  • FDA 510(k) K781815 decided 27 Feb 1979 Active
  • FDA GUDID UDI-DI H67140200050 listed 23 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K781815
  2. Listed FDA GUDID H67140200050
  3. Registered EUDAMED ++H671CE019IIADM

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Hemo-Nate
Generic name
Blood transfusion filter
Model / Ref / Catalog
4020005, Needleless Filter Set
Primary DI / UDI-DI
H67140200050
Basic UDI-DI
++H671CE019IIADM
510(k) Number
FDA product code
FPB
EMDN code
Z121799 Blood transfusion instruments - other
GMDN term
Blood transfusion filter
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
880.5440
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
Size
Pore Size — 18 Micrometer

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
4020005
GUDID
Needleless Filter Set
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Blood transfusion filter

Cleared under the same submission (K781815)

Similar devices in this category

Other devices filed under BLOOD TRANSFUSION INSTRUMENTS - OTHER.

Other devices from Utah Medical Products, Inc.

See all devices from Utah Medical Products, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)