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pulse oximeter

by Shenzhen IMDK Medical Technology Co., Ltd. EUDAMED510(k)GUDID

Active United States and European Union

Ref PO-C5AT, PO-H1AO, PO-C5AO, C101H1, PO-B1AOModel C101H1, C101A2, PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT510(k) K221979

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number697391294101PO8Z Basic UDI-DIDate22 Nov 2023RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Special NumberK221979 Date16 Oct 2022ClearedStatusActive
United StatesGUDID listing GUDID Number06973912940167 UDI-DIDate16 May 2022ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceAustriaHungaryRomaniaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceSloveniaBulgariaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaPortugalSpainSpainItalyUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSpainSpainCroatiaGreeceUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaMaltaCyprusUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Recalls: none on record (FDA, checked 24 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k) · GUDID

Trade Name
pulse oximeter EUDAMED
Imdk GUDID
Generic Name
Pulse oximeter
Model / Reference
C101H1, C101A2, PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT
Primary DI / UDI-DI
06973912940167, 06973912940136, 06973912940150, 06973912940044, 06973912940143
Basic UDI-DI
697391294101PO8Z
Direct Marketing DI
06973912940167
06973912940136
06973912940150
06973912940044
06973912940143
510(k) Number
FDA Product Code
DQA 510(k)
OCH GUDID
EMDN Code
Z1203020408 Pulse oximeters
GMDN Term
Pulse oximeter
Device Class
Class IIa EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 870.2700
Market of Registration
Hungary
Austria
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent
Commercial Distribution
In Commercial Distribution

Truth per registry

3 sources · 2 fields differ

FieldEUDAMED510(k)GUDID
FDA Product CodeEUDAMED
n/a
510(k)
DQA
GUDID
OCH
Device ClassEUDAMED
Class IIa
510(k)
Class II
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000024290
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

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Properties

  • Measuring Function
  • Over-the-Counter
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (18)

  • 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
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No