← Back to catalogue
SpO2 Sensors
EUDAMEDClass IIb (EU MDR)
Ref SSD-001-S09PIRef SSD-001-W09ARef SSD-006RB-W09ANRef SSD-001-W09I
Identity
- Trade Name
- SpO2 Sensors EUDAMED
- Device Name
- SpO2 Sensors EUDAMEDSpo2 sensor EUDAMED
- Model / Reference
- SSD-001-S09PI EUDAMEDSSD-001-W09A EUDAMEDSSD-006RB-W09AN EUDAMEDSSD-001-W09I EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941691928249 EUDAMED06941691927099 EUDAMED06941691927839 EUDAMED06941691927556 EUDAMED
- Basic UDI-DI
- B-06941691928249 EUDAMEDB-06941691927099 EUDAMEDB-06941691927839 EUDAMEDB-06941691927556 EUDAMED
- EMDN Code
- C900301 PULSE OXIMETER SENSORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
SpO2 Sensors by Orantech Inc. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Pulse oximeter probe, single-use.
- APK — Apk Technology · Class II
- 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
- MasimoSET® LNCS® NeoPt-3 SpO2 Neonatal Pulse Oximeter Adhesive Sensor — MASIMO CORPORATION · Class II
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-06941691928249 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Orantech Inc.
- EUDAMED SRN
- CN-MF-000013859
- Authorised Representative
- Medten EU ApS DK-AR-000034434
Sources (4)
- EUDAMED 6793f1b0-f1d1-4e2d-b7a1-5980d2fe4a19 61 fields · synced Jul 23, 2026
- EUDAMED 44edc4e0-9a1c-4046-a36f-b4286a363855 61 fields · synced May 17, 2026
- EUDAMED 60e47219-74e3-43d2-9510-bdeb1104fba7 61 fields · synced May 18, 2026
- EUDAMED 021acf8a-0493-4eaa-b32a-3960bb26e498 61 fields · synced May 18, 2026