Skip to content

Rotina 380 Robotic

by Andreas Hettich GmbH 2 variants

Ref 3700Model 3700, 3704

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-04050674073240 Basic UDI-DI 04050674073240UDI-DIDate29 Sep 2022RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference
3700, 3704
Primary DI / UDI-DI
04050674073240
Basic UDI-DI
B-04050674073240, 04050674010019A5
Direct Marketing DI
04050674073240
EMDN Code
W02069003 Centrifuges
Device Class
Class IVD General
Class A
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000010680

From the manufacturer

Manufacturer's product page: ROTINA 380 | 380 RC Robotic

Related devices

Category: General-purpose centrifuge IVD

Other devices from Andreas Hettich GmbH

See all devices from Andreas Hettich GmbH →

Properties

  • Surgical Instrument

Other properties (10)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • New Device: No