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Sterrad Nx™ 10033-004

by Advanced Sterilization Products Services Inc.

Ref 10033-004

Sterrad Nx™ 10033-004 is a device classified as Class IIa in the EU and Class II in the US made by Advanced Sterilization Products Services Inc., registered in EUDAMED on 16 Apr 2026 (Basic UDI-DI 0705037A040000000000004MF), cleared under FDA 510(k) K220404 on 16 May 2022 (1 earlier submission) and listed in FDA GUDID since 10 Oct 2017 (UDI-DI 10705037048656), active as of 23 Oct 2026.

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K220404

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0705037A040000000000004MF Basic UDI-DI 10705037048656UDI-DIDate16 Apr 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK220404 Date16 May 2022DecidedStatusActive
United StatesGUDID listing GUDID Number10705037048656 UDI-DI Date10 Oct 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0705037A040000000000004MF registered 16 Apr 2026 Active
  • FDA 510(k) K220404 decided 16 May 2022 Active· +1 more in the status table
  • FDA GUDID UDI-DI 10705037048656 listed 10 Oct 2017 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K160818
  2. Listed FDA GUDID 10705037048656
  3. Cleared FDA 510(k) K220404
  4. Registered EUDAMED 0705037A040000000000004MF

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
STERRAD NX™ Sterilization System with ALLClear™ Technology EUDAMED
Sterrad Nx™ GUDID
Generic name
Plasma sterilizer
Model / Ref / Catalog
10033-004
Primary DI / UDI-DI
10705037048656
Basic UDI-DI
0705037A040000000000004MF
Direct marketing DI
10705037048656
510(k) Number
FDA product code
MLR
EMDN code
Z12011309 Plasma sterilisers
GMDN term
Plasma sterilizer
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
880.6860
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Plasma sterilizer

Cleared under the same submission (K160818)

Cleared under the same submission (K220404)

Similar devices in this category

Other devices filed under CLEANING, DISINFECTION AND STERILISATION INSTRUMENTS.

Other devices from Advanced Sterilization Products, Inc.

See all devices from Advanced Sterilization Products, Inc. →

Properties

  • Over-the-counter
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)