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8000sm
EUDAMEDClass IIb (EU MDR)
Ref 6836-300Model MODEL 8000SM, SOFT SENSOR MEDIUM 3MRef 6836-000Model MODEL 8000SM, SOFT SENSOR MEDIUM 1MRef 6836-800Model MODEL 8000SM-WO2, SOFT SENSOR MEDIUM WO
Identity
- Trade Name
- 8000SM EUDAMED8000SM-WO2 EUDAMED
- Device Name
- 8000SM EUDAMED8000SM-WO2 EUDAMED
- Model / Reference
- MODEL 8000SM, SOFT SENSOR MEDIUM 3M EUDAMED6836-300 EUDAMEDMODEL 8000SM, SOFT SENSOR MEDIUM 1M EUDAMED6836-000 EUDAMEDMODEL 8000SM-WO2, SOFT SENSOR MEDIUM WO EUDAMED6836-800 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00833166002232 EUDAMED00833166002225 EUDAMED00833166003499 EUDAMED
- Basic UDI-DI
- B-00833166002232 EUDAMEDB-00833166002225 EUDAMEDB-00833166003499 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
8000sm 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-00833166002232 | 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 f54e0362-1fbb-4097-a24a-8e8a8e37cc13 61 fields · synced Jul 19, 2026
- EUDAMED ac7db650-4660-4728-b37d-77e07463ca42 61 fields · synced May 18, 2026
- EUDAMED 38a31916-5c10-47b0-8d79-f25c23375ded 61 fields · synced May 18, 2026