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BD PhaSeal™ Optima 515057

by BD Switzerland Sàrl

Ref 515057

BD PhaSeal™ Optima 515057 is a device classified as Class IIa in the EU and Class II in the US made by BD Switzerland Sàrl, registered in EUDAMED on 7 Sep 2026 (Basic UDI-DI 038290HESACSUA56) and listed in FDA GUDID since 14 Apr 2021 (UDI-DI 00382905150579), active as of 24 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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number038290HESACSUA56 Basic UDI-DI 00382905150579UDI-DIDate7 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00382905150579 UDI-DI Date14 Apr 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 038290HESACSUA56 registered 7 Sep 2026 Active
  • FDA GUDID UDI-DI 00382905150579 listed 14 Apr 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00382905150579
  2. Registered EUDAMED 038290HESACSUA56

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  • Withdrawn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
Phaseal EUDAMED
BD PhaSeal™ Optima GUDID
Generic name
Luer/non-ISO80369-standardized linear connector, single-use
Device name
BD PhaSeal™ Optima Injector
Model / Ref / Catalog
515057
Primary DI / UDI-DI
00382905150579
Basic UDI-DI
038290HESACSUA56
FDA product code
ONB
EMDN code
A0704 Systems for reconstitution and administration of pharmaceuticals
GMDN term
Luer/non-ISO80369-standardized linear connector, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
880.5440
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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: Luer/non-ISO80369-standardized linear connector, single-use

Similar devices in this category

Other devices filed under SYSTEMS FOR RECONSTITUTION AND ADMINISTRATION OF PHARMACEUTICALS.

Other devices from BD Switzerland Sàrl

See all devices from BD Switzerland Sàrl →

Properties

  • Supplied sterile
  • Single use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Administering medicine
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)