Sterile Pulse Oximeter Probe S0005J-LPS
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Identity
- Trade Name
- Sterile Pulse Oximeter Probe EUDAMED
- Device Name
- Sterile Pulse Oximeter Probe EUDAMED
- Model / Reference
- S0005J-LPS EUDAMEDS0026L-LS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944414033916 EUDAMED06944414080088 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
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
Yes
Incorporates Medicinal Product
No
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.
- APK — Apk Technology · Class II
- Spo2 sensor — Orantech Inc. · Class IIb
- MasimoSET® M-LNCS™ NeoPt SpO2 Neonatal Pulse Oximeter Adhesive Sensor — MASIMO CORPORATION · Class II
- Reusable Soft SpO2 Sensor — METKO MEDİKAL VE TIBBİ CİHAZLAR DIŞ TİCARET SANAYİ ANONİM ŞİRKETİ · Class IIb
- M-LNCS — MASIMO CORPORATION · Class II
- APK — Apk Technology · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- MasimoSET® LNCS® NeoPt Neonatal Pulse Oximeter Adhesive Sensor — MASIMO CORPORATION · Class II
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
FDA_510K
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K113727 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K212752 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 69444140106SV | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shenzhen Med-link Electronics Tech Co., Ltd.
- 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