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Reusable Pulse Oximetry Soft Sensors
EUDAMEDClass IIb (EU MDR)
Ref 110364-001Model MODEL 8000SS, SOFT SENSOR SMALL 1M, INMETRORef 110365-002Model MODEL 8000SM, SOFT SENSOR MEDIUM 3M, INMETRORef 2195-000Model MODEL 8000S, PATIENT SIMULATORRef 110364-002Model MODEL 8000SS, SOFT SENSOR SMALL 3M, INMETRO
Identity
- Trade Name
- Reusable Pulse Oximetry Soft Sensors EUDAMED
- Device Name
- Reusable Pulse Oximetry Soft Sensors EUDAMEDReusable Pulse Oximetry Soft Sensor EUDAMED
- Model / Reference
- MODEL 8000SS, SOFT SENSOR SMALL 1M, INMETRO EUDAMED110364-001 EUDAMEDMODEL 8000SM, SOFT SENSOR MEDIUM 3M, INMETRO EUDAMED110365-002 EUDAMEDMODEL 8000S, PATIENT SIMULATOR EUDAMED2195-000 EUDAMEDMODEL 8000SS, SOFT SENSOR SMALL 3M, INMETRO EUDAMED110364-002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00849686066562 EUDAMED00849686066494 EUDAMED00833166006124 EUDAMED00849686066500 EUDAMED
- Basic UDI-DI
- B-00849686066562 EUDAMEDB-00849686066494 EUDAMEDB-00833166006124 EUDAMEDB-00849686066500 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
Reusable Pulse Oximetry Soft Sensors by Nonin Medical, Inc. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Pulse oximeter probe, single-use.
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- 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00849686066562 | 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 (4)
- EUDAMED 1cee0afa-76e2-4e92-a706-0ae6fc4ec579 61 fields · synced Aug 2, 2026
- EUDAMED 5fa691bb-3f30-452b-a32d-8c50ee2ba3c1 61 fields · synced May 11, 2026
- EUDAMED 4899c461-93d8-45eb-835f-be703ad63471 61 fields · synced May 18, 2026
- EUDAMED 65299c05-08c7-4d7b-af08-7c9a2c7ae6df 61 fields · synced May 19, 2026