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NPS3 091656-001

by Raumedic AG

Ref 091656-001

NPS3 091656-001 is a device classified as Class IIb in the EU and Class II in the US made by Raumedic AG, registered in EUDAMED on 11 Sep 2026 (Basic UDI-DI 4057834NPS30032SH) and listed in FDA GUDID since 18 Aug 2016 (UDI-DI 04057834024685), active as of 12 Nov 2026.

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

CE MDR

Valid until

No date given

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

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4057834NPS30032SH Basic UDI-DI 04057834024685UDI-DIDate11 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04057834024685 UDI-DI Date18 Aug 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4057834NPS30032SH registered 11 Sep 2026 Active
  • FDA GUDID UDI-DI 04057834024685 listed 18 Aug 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04057834024685
  2. Registered EUDAMED 4057834NPS30032SH

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  • Withdrawn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
NPS3
Generic name
Invasive-detection multi-parameter physiological monitor, reusable
Model / reference
091656-001
Primary DI / UDI-DI
04057834024685
Basic UDI-DI
4057834NPS30032SH
FDA product code
GWM
EMDN code
Z12030299 Vital signs monitoring instruments - other
GMDN term
Invasive-detection multi-parameter physiological monitor, reusable
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
882.1620
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 IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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: Invasive-detection multi-parameter physiological monitor, reusable

Similar devices in this category

Other devices filed under VITAL SIGNS MONITORING INSTRUMENTS - OTHER.

Other devices from Raumedic AG

See all devices from Raumedic AG →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)