Spo2 sensor

EUDAMED

Class IIb (EU MDR)

Ref SS-001XC-AS10

by Orantech Inc.

Identity

Trade Name: Spo2 sensor EUDAMED
Device Name: Spo2 sensor EUDAMED
Model / Reference: SS-001XC-AS10 EUDAMED

Identifiers

Primary DI / UDI-DI: 06941691909330 EUDAMED
Basic UDI-DI: B-06941691909330 EUDAMED
EMDN Code: C900301 PULSE OXIMETER SENSORS EUDAMED

Classification

Device Class: Class IIb EUDAMED
Market of Registration: Denmark EUDAMED

Clinical & Handling

Sterile

EUDAMED

Implantable

EUDAMED

Reusable

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

EUDAMED

Category: Pulse oximeter probe, single-use

Spo2 sensor by Orantech Inc. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS

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Also classified as Pulse oximeter probe, single-use.

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Unimed — Unimed Medical Supplies, Inc. · Class II
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MasimoSET® LNCS® NeoPt-3 SpO2 Neonatal Pulse Oximeter Adhesive Sensor — MASIMO CORPORATION · Class II

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDD	B-06941691909330	Class IIb	Active

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Manufacturer

Manufacturer: Orantech Inc.
EUDAMED SRN: CN-MF-000013859
Authorised Representative: Medten EU ApS DK-AR-000034434

Sources (1)

EUDAMED 87b625f0-8a61-4282-965c-7f6876740b9e 61 fields · synced May 23, 2026