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Disposable Spo2 sensors
EUDAMEDClass IIb (EU MDR)
Ref XDANModel C900301 - PULSE OXIMETER SENSORSRef XDBNRef XDPN
Identity
- Trade Name
- Disposable Spo2 sensors EUDAMED
- Device Name
- Disposable SpO2 Sensors EUDAMED
- Model / Reference
- C900301 - PULSE OXIMETER SENSORS EUDAMEDXDAN EUDAMEDXDBN EUDAMEDXDPN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974264560010 EUDAMED06974264560041 EUDAMED06974264560034 EUDAMED
- Basic UDI-DI
- 6974264560000000002NQ 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
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
Disposable 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
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- MasimoSET® M-LNCS™ NeoPt SpO2 Neonatal Pulse Oximeter Adhesive Sensor — MASIMO CORPORATION · Class II
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- 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 | 6974264560000000002NQ | Class IIb | Active |
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Manufacturer
- Manufacturer
- Xinkang Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000011906
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (3)
- EUDAMED ae0754d3-9d44-49bc-8795-7dbd9d37e8c4 61 fields · synced Oct 6, 2026
- EUDAMED 778cc04c-8baa-48bf-937a-2bd4f4896b9f 61 fields · synced May 17, 2026
- EUDAMED 34b842f4-7c85-4522-83e8-97ed96b7426f 61 fields · synced May 18, 2026