← Back to catalogue
SpO2 sensor
EUDAMEDClass IIb (EU MDR)
Ref S2NG30-001Model S2AF30-001，S2AF11-149，S2AF11-101，S2PF30-001，S2AS30-001，S2PS30-001 and S2NG30-001
Identity
- Device Name
- SpO2 sensor EUDAMED
- Model / Reference
- S2AF30-001，S2AF11-149，S2AF11-101，S2PF30-001，S2AS30-001，S2PS30-001 and S2NG30-001 EUDAMEDS2NG30-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976725850173 EUDAMED
- Basic UDI-DI
- 6976725851845HE EUDAMED
- Direct Marketing DI
- 06976725850173 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 |
Is this your device? Claim it to add documentation and request validation.
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 c166656d-0c36-402f-ac98-78a6011e70b2 61 fields · synced Jun 18, 2026