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Procleix Panther System

by Grifols Diagnostic Solutions Inc. 2 variants

Ref 303160

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

CE IVDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number0850032683Panther001B4 Basic UDI-DI 00850032683609UDI-DIDate29 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00850032683609 UDI-DI Date13 Jul 2026ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic Name
Donor blood/tissue testing analyser IVD
Model / Ref / Catalog
303160, Procleix Panther System
Primary DI / UDI-DI
00850032683609
Basic UDI-DI
0850032683Panther001B4
Direct Marketing DI
00850032683609
EMDN Code
W02050116 Nucleic acid testing integrated extraction /amplification /detection systems
GMDN Term
Donor blood/tissue testing analyser IVD
Device Class
Class A
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
303160
GUDID
Procleix Panther System

Other devices from Grifols Diagnostic Solutions Inc.

See all devices from Grifols Diagnostic Solutions Inc. →

Properties

  • Professional Testing
  • Surgical Instrument
  • Serial Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No