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8000sl
EUDAMEDClass IIb (EU MDR)
Ref 8299-001Model 70413, MODEL 8000SL SOFT SNSR LRGE 1MRef 6835-800Model MODEL 8000SL, SOFT SENSOR LARGE SL-WO2
Identity
- Trade Name
- 8000SL EUDAMED
- Device Name
- 8000SL EUDAMED
- Model / Reference
- 70413, MODEL 8000SL SOFT SNSR LRGE 1M EUDAMED8299-001 EUDAMEDMODEL 8000SL, SOFT SENSOR LARGE SL-WO2 EUDAMED6835-800 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00833166004373 EUDAMED00833166003482 EUDAMED
- Basic UDI-DI
- B-00833166004373 EUDAMEDB-00833166003482 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
8000sl 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-00833166004373 | 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 a0c5ffb4-5de1-4deb-8f0b-34c997cb048e 61 fields · synced Jul 31, 2026
- EUDAMED 49ba7557-63b3-4304-bf58-4192536f5a36 61 fields · synced May 18, 2026