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Rhythm Healthcare P2-S4

by Qingdao Kingon Medical Science and Technology Co., Ltd

Ref P2-S4Model P2-K3 P2-K4 P2-S3 P2-S4

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

CE MDR

Valid until

5 Jun 2030

CE MDR certificate

FDA recalls

None found

in data synced 22 Oct 2026

Documents

1 certificate

Certifier SGS FIMKO OY

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 NumberFI25/1008016 Date28 Aug 2026IssuedStatusActive expires 5 Jun 2030
United StatesGUDID listing GUDID Number06971882890482 UDI-DI Date23 Oct 2023ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • FI25/1008016 Active Supplemented

    Quality management system EU MDR

    Certifier
    SGS FIMKO OY 0598
    Issued
    28 Aug 2026
    Expires
    5 Jun 2030
    Reason
    Other

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  • Withdrawn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
Portable Oxygen Concentrator EUDAMED
Rhythm Healthcare GUDID
Generic Name
Mobile/portable oxygen concentrator
Model / Reference
P2-S4, P2-K3 P2-K4 P2-S3 P2-S4
Primary DI / UDI-DI
06971882890482 EUDAMED
06971882890239 GUDID
Basic UDI-DI
697188289P2-K/SKK
Direct Marketing DI
06971882890482
510(k) Number
FDA Product Code
CAW
EMDN Code
Z12159004 Oxygen concentrators
GMDN Term
Mobile/portable oxygen concentrator
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
868.5440
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
06971882890482
GUDID
06971882890239
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Cleared under the same submission (K230702)

Other devices from Qingdao Kingon Medical Science and Technology Co., Ltd

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Properties

  • Single Use
  • Serial Number
  • Manufacturing Date

Other properties (21)

  • Sterile: 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