← Back to catalogue
Reusable SpO2 Sensors
EUDAMEDClass IIb (EU MDR)
Ref XSAF4Ref XSPS2Ref XSPS4Ref XSAS3Ref XSPS3Ref XSAS4Ref XSPF2Ref XSIS3Ref XSNS3Ref XSAE3Ref XSAS2Ref XSPF4Ref XSAF3
Identity
- Device Name
- Reusable SpO2 Sensors EUDAMED
- Model / Reference
- XSAF4 EUDAMEDXSPS2 EUDAMEDXSPS4 EUDAMEDXSAS3 EUDAMEDXSPS3 EUDAMEDXSAS4 EUDAMEDXSPF2 EUDAMEDXSIS3 EUDAMEDXSNS3 EUDAMEDXSAE3 EUDAMEDXSAS2 EUDAMEDXSPF4 EUDAMEDXSAF3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974264560133 EUDAMED06974264560126 EUDAMED06974264560164 EUDAMED06974264560188 EUDAMED06974264560201 EUDAMED06974264560140 EUDAMED06974264560119 EUDAMED06974264560089 EUDAMED06974264560027 EUDAMED06974264560065 EUDAMED06974264560102 EUDAMED06974264560157 EUDAMED06974264560171 EUDAMED
- Basic UDI-DI
- 6974264560000000001NN EUDAMED
- EMDN Code
- C900301 PULSE OXIMETER SENSORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Reusable SpO2 Sensors by Xinkang Medical Instrument Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6974264560000000001NN | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Xinkang Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000011906
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (13)
- EUDAMED e2b6aba1-eb84-4ab1-b77b-17bc43dd83ac 61 fields · synced Sep 17, 2026
- EUDAMED 20a41946-3a7b-48ea-99c3-1ec157235519 61 fields · synced May 16, 2026
- EUDAMED 5836cb10-628f-42fa-8138-9ae42fe41fdc 61 fields · synced May 17, 2026
- EUDAMED cb1b2a17-38cc-44b1-8d5d-74b890024f61 61 fields · synced May 17, 2026
- EUDAMED 6a257daa-c58d-4bce-9d8c-a3ed4af277e9 61 fields · synced May 17, 2026
- EUDAMED c03157c2-5ddb-4452-8f79-5391a0a3b6b3 61 fields · synced May 17, 2026
- EUDAMED 6b0e002e-a455-49bb-97bc-87423afeb170 61 fields · synced May 18, 2026
- EUDAMED d70d2511-c447-48aa-b747-d7a19b7a2366 61 fields · synced May 18, 2026
- EUDAMED 662bee09-d69b-44a5-b668-7377ceeac319 61 fields · synced May 18, 2026
- EUDAMED 38c0ca1e-c186-4602-8685-ce9be8a5ac7e 61 fields · synced May 18, 2026
- EUDAMED 17778adc-36d6-466c-a794-fd99dd901502 61 fields · synced May 18, 2026
- EUDAMED c1656b82-1aa5-4236-b331-351f46f2ed21 61 fields · synced May 18, 2026
- EUDAMED 779698ef-46df-41cb-adfe-c1847c789b03 61 fields · synced May 18, 2026