Skip to content

Halyard 53605

by O&M Halyard Inc.

Ref 53605

Halyard 53605 is a Class I device made by O&M Halyard Inc., registered in EUDAMED on 11 Sep 2026 (Basic UDI-DI 06806517SIPA001KE) and listed in FDA GUDID since 18 Nov 2020 (UDI-DI 20680651536055), active as of 23 Oct 2026.

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

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number06806517SIPA001KE Basic UDI-DI 20680651536055UDI-DIDate11 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number20680651536055 UDI-DI Date18 Nov 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 06806517SIPA001KE registered 11 Sep 2026 Active
  • FDA GUDID UDI-DI 20680651536055 listed 18 Nov 2020 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID 20680651536055
  2. Registered EUDAMED 06806517SIPA001KE

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  • Withdrawn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
Halyard
Generic name
Tourniquet cuff bandage, non-latex
Device name
SIP Accessories
Model / Ref / Catalog
53605
Primary DI / UDI-DI
20680651536055
Basic UDI-DI
06806517SIPA001KE
FDA product code
IPM
EMDN code
V80 Clinical use accessories not included in other classes
GMDN term
Tourniquet cuff bandage, non-latex
Device class
Class I
Regulation number
890.3025
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Related devices

Category: Tourniquet cuff bandage, non-latex

Similar devices in this category

Other devices filed under CLINICAL USE ACCESSORIES NOT INCLUDED IN OTHER CLASSES.

Other devices from O&M Halyard Inc.

See all devices from O&M Halyard Inc. →

Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)