Identity
- Trade Name
- SP8119A EUDAMED
- Device Name
- SPO2 Sensor EUDAMED
- Model / Reference
- SP8119A EUDAMED07-10-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972820960557 EUDAMED
- Basic UDI-DI
- B-06972820960557 EUDAMED
- EMDN Code
- C900301 PULSE OXIMETER SENSORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Pulse oximeter probe, single-use
Sp8119a by Shenzhen SINO-K Medical Technology Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Pulse oximeter probe, single-use.
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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-06972820960557 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shenzhen SINO-K Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000021157
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (1)
- EUDAMED febedf72-d6b1-4d41-b278-bd7f28d455b2 61 fields · synced Jun 18, 2026