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Sterile Pulse Oximeter Probe S0005J-LPS

EUDAMEDFDA 510(k)

Class IIb (EU MDR)

Ref S0005J-LPSRef S0026L-LS

by Shenzhen Med-link Electronics Tech Co., Ltd.

Identity

Trade Name
Sterile Pulse Oximeter Probe EUDAMED
Device Name
Sterile Pulse Oximeter Probe EUDAMED
Model / Reference
S0005J-LPS EUDAMED
S0026L-LS EUDAMED

Identifiers

Primary DI / UDI-DI
06944414033916 EUDAMED
06944414080088 EUDAMED
Basic UDI-DI
69444140106SV EUDAMED
EMDN Code
C900301 PULSE OXIMETER SENSORS EUDAMED

Classification

Device Class
Class IIb EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Category: Pulse oximeter probe, single-use

This device is a sterile pulse oximeter probe (Nomenclature Code: C900301), classified as a Class IIb medical device. It measures oxygen saturation (SpO₂) and pulse rate non-invasively by transmitting and detecting light through tissue, providing real-time physiological monitoring for patients.

The probe is single-use, sterile, and non-reusable, designed for clinical settings where infection control is critical. Supplied in a sterile package, it is compatible with standard pulse oximetry monitors and adheres to FDA 510(k) and MDR regulatory standards. Storage requires adherence to manufacturer guidelines to maintain sterility and functionality.

Similar devices

Also classified as Pulse oximeter probe, single-use.

Frequently asked questions

What clinical purpose does this sterile pulse oximeter probe serve in patient care?

This sterile pulse oximeter probe is designed for non-invasive, real-time monitoring of a patient’s oxygen saturation (SpO₂) and pulse rate. It is particularly useful in clinical settings where infection control is critical, such as operating rooms, intensive care units, or emergency departments, to continuously track vital signs without invasive procedures.

Is this probe reusable, or is it intended for single-use only?

The probe is explicitly designed for single-use only and is not reusable. It is supplied sterile in a sealed package, ensuring infection control standards are met for each patient use. Reusing it would compromise sterility and patient safety.

How should I store this device to maintain its sterility and functionality?

Storage must follow the manufacturer’s guidelines to preserve sterility and performance. The probe should be kept in its original, unopened sterile packaging until use, away from extreme temperatures, moisture, or direct sunlight. Avoid exposing it to conditions that could damage the adhesive or sensor components.

What regulatory pathways does this device follow, and who is the authorized representative in Europe?

This device has been authorized through FDA 510(k) clearance and MDR (Medical Device Regulation) compliance. In Europe, the authorized representative is Shanghai International Holding Corp. GmbH (Europe), registered under SRN DE-AR-000000001.

Can this probe be used with any standard pulse oximetry monitor, or are there compatibility restrictions?

The probe is designed to be compatible with standard pulse oximetry monitors, but compatibility may depend on the specific monitor’s sensor interface. Always verify with the manufacturer’s documentation or your monitor’s user guide to ensure proper fit and functionality before use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: MED-LINKET - SpO2 sensors-ECG/ lead wires-NIBP-EEG Electrodes ..., Med-linket Corp, Products - Shenzhen Med-Link Electronics Tech Co.,Ltd, About Us - Shenzhen Med-link Electronics Tech Co., Ltd.

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
CN-MF-000011145
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (3)

  • EUDAMED 23087056-14e1-4370-b283-ca80df26c359 61 fields · synced Sep 18, 2026
  • EUDAMED 898fdacb-0fe7-4c8f-8554-b1e2a3467a52 61 fields · synced Jul 8, 2026
  • FDA 510(k) K113727 1 fields · synced May 18, 2026