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SpO2 Sensor
EUDAMEDClass IIb (EU MDR)
Ref S1PW09-001Model S1AW09-001，S1PW09-001，S1FW09-001，S1FW09-101 and S1FW09-149.
Identity
- Device Name
- SpO2 Sensor EUDAMED
- Model / Reference
- S1AW09-001，S1PW09-001，S1FW09-001，S1FW09-101 and S1FW09-149. EUDAMEDS1PW09-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976725856038 EUDAMED
- Basic UDI-DI
- 6976725851846HG EUDAMED
- Direct Marketing DI
- 06976725856038 EUDAMED
- EMDN Code
- C900301 PULSE OXIMETER SENSORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Portugal 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
SpO2 Sensor by Shenzhen Redy-Med Technology Co., Ltd — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 6976725851846HG | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shenzhen Redy-Med Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000029812
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (1)
- EUDAMED bcb278b7-1ba2-4218-85fb-16b5a79e121a 61 fields · synced Jun 18, 2026