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SenSmart Ad. & Ped. C/S Sensor
EUDAMEDClass IIb (EU MDR)
Ref 10433-001Model 8204CA
Identity
- Trade Name
- SenSmart Ad. & Ped. C/S Sensor EUDAMED
- Device Name
- SenSmart Ad. & Ped. C/S Sensor EUDAMED
- Model / Reference
- 8204CA EUDAMED10433-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00849686085723 EUDAMED
- Basic UDI-DI
- B-00849686085723 EUDAMED
- EMDN Code
- C900301 PULSE OXIMETER SENSORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Netherlands 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
SenSmart Ad. & Ped. C/S Sensor by Nonin Medical, 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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- APK — Apk Technology · Class II
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- 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00849686085723 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Nonin Medical, Inc.
- EUDAMED SRN
- US-MF-000008228
- Authorised Representative
- MPS Medical Product Service GmbH DE-AR-000005009
Sources (1)
- EUDAMED eaff2f8b-d5b6-4479-b981-cf0bad286ffd 61 fields · synced Jun 17, 2026