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PAXgene® Blood RNA Tube 762165

by Preanalytix GmbH

Ref 762165

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 22 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number4053727OQXSHDWXHN Basic UDI-DI 04053727621658UDI-DIDate10 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04053727621658 UDI-DI Date25 Oct 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 22 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  • Withdrawn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 RNA Tube GUDID
Generic Name
Evacuated blood collection tube IVD, nucleic acid stabilizer
Model / Ref / Catalog
762165
Primary DI / UDI-DI
04053727621658
Basic UDI-DI
4053727OQXSHDWXHN
FDA Product Code
NTW
EMDN Code
W050101010201 Blood collection, tubes with additives or serum separator
GMDN Term
Evacuated blood collection tube IVD, nucleic acid stabilizer
Device Class
Class A EUDAMED
Class II GUDID
Regulation Number
866.4070
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Size
Length — 100 Millimeter
Total Volume — 2.5 Milliliter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class A
GUDID
Class II

Related devices

Cleared under the same submission (K082150)

Other devices from Preanalytix GmbH

Properties

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

Other properties (15)

  • Implantable: No
  • Contains Latex: No
  • Human 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