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SpO2 sensor
EUDAMEDClass IIb (EU MDR)
Ref S2AF11-149Model S2AF30-001，S2AF11-149，S2AF11-101，S2PF30-001，S2AS30-001，S2PS30-001 and S2NG30-001Ref S1AW09-001Model S1AW09-001，S1PW09-001，S1FW09-001，S1FW09-101 and S1FW09-149.Ref S2AF11-101Ref S1FW09-101Ref S2PS30-001
Identity
- Device Name
- SpO2 sensor EUDAMED
- Model / Reference
- S2AF30-001，S2AF11-149，S2AF11-101，S2PF30-001，S2AS30-001，S2PS30-001 and S2NG30-001 EUDAMEDS2AF11-149 EUDAMEDS1AW09-001，S1PW09-001，S1FW09-001，S1FW09-101 and S1FW09-149. EUDAMEDS1AW09-001 EUDAMEDS2AF11-101 EUDAMEDS1FW09-101 EUDAMEDS2PS30-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976725859688 EUDAMED06976725856021 EUDAMED06976725859671 EUDAMED06976725856700 EUDAMED06976725850159 EUDAMED
- Basic UDI-DI
- 6976725851845HE EUDAMED6976725851846HG EUDAMED
- Direct Marketing DI
- 06976725859688 EUDAMED06976725856021 EUDAMED06976725859671 EUDAMED06976725856700 EUDAMED06976725850159 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
Category: Pulse oximeter probe, single-use
SpO2 sensor by Shenzhen Redy-Med Technology 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 | 6976725851845HE | 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 (5)
- EUDAMED 9a70a7a1-63c8-41f5-93f0-f38d2e343964 61 fields · synced Jul 15, 2026
- EUDAMED 81e9f61f-7b72-4a94-b3f2-5c3579ff5c55 61 fields · synced May 17, 2026
- EUDAMED 9cc35379-0c0f-4af7-870b-5801d133ad43 61 fields · synced May 17, 2026
- EUDAMED f854122d-6c65-419c-9260-a4449714e554 61 fields · synced May 17, 2026
- EUDAMED 6509b4f6-505d-4437-8bc8-b5a28fee4123 61 fields · synced May 17, 2026