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Spo2 sensors
EUDAMEDClass IIb (EU MDR)
Ref Directive 93/42/EEC on Medical Devices (MDD), Annex Il excluding (4)(Devices in Class Ila, Ilb or Ill)Model P5119
Identity
- Trade Name
- Spo2 sensors EUDAMED
- Device Name
- Spo2 sensors EUDAMED
- Model / Reference
- P5119 EUDAMEDDirective 93/42/EEC on Medical Devices (MDD), Annex Il excluding (4)(Devices in Class Ila, Ilb or Ill) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971018114987 EUDAMED
- Basic UDI-DI
- B-06971018114987 EUDAMED
- EMDN Code
- C900301 PULSE OXIMETER SENSORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Pulse oximeter probe, single-use
Spo2 sensors by Shenzhen Medke Technology Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Pulse oximeter probe, single-use.
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- 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/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06971018114987 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shenzhen Medke Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000019638
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 9d35ce4c-480e-4904-bffa-4b20a0c47d27 61 fields · synced Jul 14, 2026
- EUDAMED 9d35ce4c-480e-4904-bffa-4b20a0c47d27-1 61 fields · synced Jun 9, 2026