Identity
- Trade Name
- Spo2 sensor EUDAMED
- Device Name
- Spo2 sensor EUDAMED
- Model / Reference
- SS-008RB-AF36 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941691954699 EUDAMED
- Basic UDI-DI
- B-06941691954699 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Pulse oximeter probe, single-use
Spo2 sensor by Orantech Inc. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Pulse oximeter probe, single-use.
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- Unimed — Unimed Medical Supplies, Inc. · Class II
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- 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-06941691954699 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Orantech Inc.
- EUDAMED SRN
- CN-MF-000013859
- Authorised Representative
- Medten EU ApS DK-AR-000034434
Sources (1)
- EUDAMED 2ff22b23-78bd-4790-9fba-4527ec2300ce 61 fields · synced May 23, 2026