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Pulse Oximeter System
EUDAMEDClass IIb (EU MDR)
Ref 7500-0303Model MODEL 7500, 8000AA-2, PCS-EU
Identity
- Trade Name
- Pulse Oximeter System EUDAMED
- Device Name
- Pulse Oximeter System EUDAMED
- Model / Reference
- MODEL 7500, 8000AA-2, PCS-EU EUDAMED7500-0303 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00849686098525 EUDAMED
- Basic UDI-DI
- B-00849686098525 EUDAMED
- EMDN Code
- Z1203020408 PULSE OXIMETERS 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
Pulse Oximeter System by Nonin Medical, Inc. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-00849686098525 | 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 e8bca6c5-4999-415a-867a-6afdedec1de8 61 fields · synced Jun 18, 2026