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Infant/ Pediatric Fiber Optic Sensor
EUDAMEDClass IIb (EU MDR)
Ref 6079-000Model MODEL 8000FI-30, INF/PED FIBER OPTIC SENSORRef 6079-001Model MODEL 8000FI-20, INF/PED FIBER OPTIC SENSOR
Identity
- Trade Name
- Infant/ Pediatric Fiber Optic Sensor EUDAMED
- Device Name
- Infant/ Pediatric Fiber Optic Sensor EUDAMED
- Model / Reference
- MODEL 8000FI-30, INF/PED FIBER OPTIC SENSOR EUDAMED6079-000 EUDAMEDMODEL 8000FI-20, INF/PED FIBER OPTIC SENSOR EUDAMED6079-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00833166000733 EUDAMED00833166000726 EUDAMED
- Basic UDI-DI
- B-00833166000733 EUDAMEDB-00833166000726 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
Infant/ Pediatric Fiber Optic 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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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-00833166000733 | 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 (2)
- EUDAMED 108fa4c9-571c-4763-b7b6-74786bbb965f 61 fields · synced Jul 22, 2026
- EUDAMED 1124a6d7-2f6d-423b-b06e-a44e675f759e 61 fields · synced May 17, 2026