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Savanna 20382

by Diagnostic Hybrids, Inc.

Ref 20382Model Savanna

Savanna 20382 is a device classified as Class A in the EU and Class II in the US made by Diagnostic Hybrids, Inc., registered in EUDAMED on 21 Oct 2026 (Basic UDI-DI 0014613MF3TF5MZCCzhDfvABZ), cleared under FDA 510(k) K232286 on 20 Dec 2023 and listed in FDA GUDID since 30 Apr 2024 (UDI-DI 30014613339304), active as of 25 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE IVDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

510(k) K232286

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number0014613MF3TF5MZCCzhDfvABZ Basic UDI-DI 30014613339304UDI-DIDate21 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number30014613339304 UDI-DI Date30 Apr 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK232286 Date20 Dec 2023DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0014613MF3TF5MZCCzhDfvABZ registered 21 Oct 2026 Active
  • FDA 510(k) K232286 decided 20 Dec 2023 Active
  • FDA GUDID UDI-DI 30014613339304 listed 30 Apr 2024 Listed

Certificates

0 certificates · EUDAMED

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

Timeline

3 dated events

  1. Cleared FDA 510(k) K232286
  2. Listed FDA GUDID 30014613339304
  3. Registered EUDAMED 0014613MF3TF5MZCCzhDfvABZ

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Savanna Instrument EUDAMED
Savanna GUDID
Generic name
Thermal cycler nucleic acid amplification analyser IVD, point-of-care
Device name
Instrument
Model / Ref / Catalog
20382, Savanna
Primary DI / UDI-DI
30014613339304
Basic UDI-DI
0014613MF3TF5MZCCzhDfvABZ
510(k) Number
FDA product code
OOI
EMDN code
W02050301 Nucleic acid testing apparatuses - rapid and point of care tests
GMDN term
Thermal cycler nucleic acid amplification analyser IVD, point-of-care
Device class
Class A EUDAMED
Class II GUDID
Regulation number
862.2570
Special device type
Software
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class A
GUDID
Class II

Device class is stated on each registry's own scale: Class A in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Thermal cycler nucleic acid amplification analyser IVD, point-of-care

Cleared under the same submission (K232286)

Similar devices in this category

Other devices filed under NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS.

Other devices from Diagnostic Hybrids, Inc.

See all devices from Diagnostic Hybrids, Inc. →

Properties

  • Single use
  • Professional testing
  • IVD instrument
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)