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PSMA, EP192, RMab

by Bio SB Inc 3 variants

Ref BSB 6349

PSMA, EP192, RMab (BSB 6349) is a device classified as IVD General (EU), Class I (US) made by Bio Sb, Inc., registered in EUDAMED on 6 Dec 2025 (Basic UDI-DI B-B502BSB63490) and listed in FDA GUDID since 16 Mar 2020 (UDI-DI B502BSB63490), active as of 22 Oct 2026.

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

CE IVDD

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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-B502BSB63490 Basic UDI-DI B502BSB63490UDI-DIDate6 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID NumberB502BSB63490 UDI-DI Date16 Mar 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-B502BSB63490 registered 6 Dec 2025 Active
  • FDA GUDID UDI-DI B502BSB63490 listed 16 Mar 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID B502BSB63490
  2. Registered EUDAMED B-B502BSB63490

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
PSMA, EP192, RMab EUDAMED
PSMA RMab GUDID
Generic name
Prostate-specific membrane antigen (PSMA) IVD, antibody
Model / Ref / Catalog
BSB 6349, Concentrate, 0.5 ml
Primary DI / UDI-DI
B502BSB63490
Basic UDI-DI
B-B502BSB63490
FDA product code
NJT
EMDN code
W01030709 Primary antisera for immunohistology
GMDN term
Prostate-specific membrane antigen (PSMA) IVD, antibody
Device class
Class IVD General EUDAMED
Class I GUDID
Regulation number
864.1860
EU registration type
Legacy device (under a directive)
EU market of registration
Sweden
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
BSB 6349
GUDID
Concentrate, 0.5 ml
Device classEUDAMED
Class IVD General
GUDID
Class I

Manufacturer details

EUDAMED SRN
US-MF-000036462
Authorised representative
QAdvis EAR AB SE-AR-000001599

Other devices from Bio Sb, Inc.

See all devices from Bio Sb, Inc. →

Properties

  • Contains animal tissues or cells
  • Reagent
  • Professional testing
  • Premarket exempt
Other properties (22, all answered No)