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Pulse Oximeter

by Edan Instruments, Inc.

Ref H100N

Pulse Oximeter (H100N) is a Class IIb device made by Edan Instruments, Inc., registered in EUDAMED on 29 Jan 2026 (Basic UDI-DI 69444138H100SF9), active as of 23 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69444138H100SF9 Basic UDI-DI 06944413800588UDI-DIDate29 Jan 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / reference
H100N
Primary DI / UDI-DI
06944413800588
Basic UDI-DI
69444138H100SF9
EMDN code
Z1203020408 Pulse oximeters
Device class
Class IIb
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000009957
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Similar devices in this category

Other devices filed under PULSE OXIMETERS.

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Properties

  • Measuring function
Other properties (13, all answered No)