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Rotixa 500 Rs, 230-240V 50HZ + 220V 60HZ

by Andreas Hettich GmbH 2 variants

Ref 4950

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

CE MDR

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/MDR EUDAMED Number040506740100029L Basic UDI-DI 04050674075572UDI-DIDate16 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04050674075572 UDI-DI Date2 Sep 2021ListedStatusListed 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  • Withdrawn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/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Rotixa 500 Rs, 230-240V 50HZ + 220V 60HZ EUDAMED
Rotixa 500 Rs GUDID
Generic Name
Blood bank centrifuge
Model / Ref / Catalog
4950, ROTIXA 500, Standard
Primary DI / UDI-DI
04050674075572
Basic UDI-DI
040506740100029L
Direct Marketing DI
04050674075572
FDA Product Code
QBV
EMDN Code
W02069005 Refrigerated centrifuges
GMDN Term
Blood bank centrifuge
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
862.2050
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
4950
GUDID
ROTIXA 500, Standard
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
DE-MF-000010680

From the manufacturer

Manufacturer's product page: ROTIXA 500 RS

Other devices from Andreas Hettich GmbH

See all devices from Andreas Hettich GmbH →

Properties

  • Over-the-Counter
  • Premarket Exempt
  • Serial Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No