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SpO2 sensor
EUDAMEDClass IIb (EU MDR)
Ref S2AF30-001Model S2AF30-001，S2AF11-149，S2AF11-101，S2PF30-001，S2AS30-001，S2PS30-001 and S2NG30-001Ref S2PF30-001Ref RD130F-29 Model RD130F-29,RD130S-29
Identity
- Device Name
- SpO2 sensor EUDAMED
- Model / Reference
- S2AF30-001，S2AF11-149，S2AF11-101，S2PF30-001，S2AS30-001，S2PS30-001 and S2NG30-001 EUDAMEDS2AF30-001 EUDAMEDS2PF30-001 EUDAMEDRD130F-29,RD130S-29 EUDAMEDRD130F-29 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976725850111 EUDAMED06976725850142 EUDAMEDD-CN-MF-000029812TM EUDAMED
- Basic UDI-DI
- 6976725851845HE EUDAMEDB-CN-MF-000029812TM EUDAMED
- Direct Marketing DI
- 06976725850111 EUDAMED06976725850142 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 — MDD, 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/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 6976725851845HE | Class IIb | Active |
| 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 (3)
- EUDAMED e3ec6a24-d6cf-49bd-ba07-19e2be2e16ff 61 fields · synced Aug 2, 2026
- EUDAMED b25d945c-0da3-4d63-a20b-da01c4f7f692 61 fields · synced May 16, 2026
- EUDAMED da7e553d-9f6a-4b39-a750-3fe97aa22981 61 fields · synced May 19, 2026