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PAXgene® Blood DNA Tube 761165

by Preanalytix GmbH

Ref 761165

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

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 Oct 2026

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 Number4053727LZCYGBEZC4 Basic UDI-DI 04053727611659UDI-DIDate10 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04053727611659 UDI-DI Date28 Jul 2016ListedStatusListed 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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

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  • Withdrawn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

Trade Name
PAXgene EUDAMED
PAXgene® Blood DNA Tube GUDID
Generic Name
Evacuated blood collection tube IVD, anticoagulant
Model / Ref / Catalog
761165
Primary DI / UDI-DI
04053727611659
Basic UDI-DI
4053727LZCYGBEZC4
510(k) Number
FDA Product Code
PJE
EMDN Code
W050101010201 Blood collection, tubes with additives or serum separator
GMDN Term
Evacuated blood collection tube IVD, anticoagulant
Device Class
Class A EUDAMED
Class II GUDID
Regulation Number
862.1675
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Size
Length — 75 Millimeter
Total Volume — 2.5 Milliliter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class A
GUDID
Class II

Related devices

Category: Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer

Other devices from Preanalytix GmbH

Properties

  • Sterile
  • Single Use
  • Professional Testing
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (16)

  • 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
  • Surgical Instrument: No
  • New Device: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No