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Oxygen Concentrator for Medical Use

by Shenyang Canta Medical Tech. Co., Ltd.

Ref HG5-WN-NS

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

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 Number695307710050769 Basic UDI-DI 06953077101221UDI-DIDate4 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number06953077101221 UDI-DI Date8 Oct 2025ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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

Trade Name
Oxygen Concentrator for Medical Use EUDAMED
Oxygen concentrator GUDID
Generic Name
Stationary oxygen concentrator
Model / Reference
HG5-WN-NS
Primary DI / UDI-DI
06953077101221 EUDAMED
06953077101177 GUDID
Basic UDI-DI
695307710050769
Direct Marketing DI
06953077101221
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
Hungary
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
06953077101221
GUDID
06953077101177
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000014660
Authorised representative
MedNet EC-REP C IIb GmbH DE-AR-000011194

Other devices from Shenyang Canta Medical Tech.Co., Ltd

See all devices from Shenyang Canta Medical Tech.Co., Ltd →

Properties

  • Serial Number
  • Manufacturing Date

Other properties (22)

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