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Mark 5 Nuvo 10

by Nidek Medical Products Inc. 2 variants

Ref 1005UK

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

CE MDR

Valid until

13 Dec 2027

CE MDR certificate

FDA recalls

None found

in data synced 22 Oct 2026

Documents

1 certificate

Certifier Intertek Medical Notified Body AB

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number00038214NIDEK4L Basic UDI-DI 00038214001469UDI-DIDate19 Sep 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number00038214001469 UDI-DI Date24 Aug 2016ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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

Generic Name
Stationary oxygen concentrator
Device Name
Nidek Medical Oxygen Concentrators
Model / Ref / Catalog
1005UK
Primary DI / UDI-DI
00038214001469
Basic UDI-DI
00038214NIDEK4L
Direct Marketing DI
00038214001469
510(k) Number
FDA Product Code
CAW
EMDN Code
Z12159004 Oxygen concentrators
GMDN Term
Stationary oxygen concentrator
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
868.5440
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

Manufacturer details

EUDAMED SRN
US-MF-000007253
Authorised representative
mdi Europa GmbH DE-AR-000006218

Other devices from Nidek Medical Products Inc.

See all devices from Nidek Medical Products Inc. →

Properties

  • Prescription Use
  • Lot / Batch Number
  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No