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Reusable Finger Clip Pulse Oximetry Sensors
EUDAMEDClass IIb (EU MDR)
Ref 110377-003Model MODEL 8000AA, FINGER CLIP SENSOR 3M, INMETRORef 10352-001Model MODEL 8100AA, REUSABLE FINGER CLIP SENSORRef 10360-001Model MODEL 8100AP, REUSABLE FINGER CLIP SENSOR
Identity
- Trade Name
- Reusable Finger Clip Pulse Oximetry Sensors EUDAMED
- Device Name
- Reusable Finger Clip Pulse Oximetry Sensors EUDAMED
- Model / Reference
- MODEL 8000AA, FINGER CLIP SENSOR 3M, INMETRO EUDAMED110377-003 EUDAMEDMODEL 8100AA, REUSABLE FINGER CLIP SENSOR EUDAMED10352-001 EUDAMEDMODEL 8100AP, REUSABLE FINGER CLIP SENSOR EUDAMED10360-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00849686066470 EUDAMED00849686070613 EUDAMED00849686070606 EUDAMED
- Basic UDI-DI
- B-00849686066470 EUDAMEDB-00849686070613 EUDAMEDB-00849686070606 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 Finger Clip Pulse Oximetry 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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- 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-00849686066470 | 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 (3)
- EUDAMED 763c8971-1416-4177-8049-b5de2991b888 61 fields · synced Jul 11, 2026
- EUDAMED 5e012677-6539-43be-8a59-a0ffebbddafe 61 fields · synced May 17, 2026
- EUDAMED a0bef9e4-bfb1-496c-8006-b3127974c695 61 fields · synced May 19, 2026