Identity
- Trade Name
- LNCS Red TFA-1 EUDAMED
- Device Name
- LNCS SET Disposable Sensors EUDAMED
- Model / Reference
- 3857 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10843997008874 EUDAMED
- Basic UDI-DI
- 084399700000Z1T1B04V106GF EUDAMED
- Unit of Use DI
- 00843997008877 EUDAMED
- EMDN Code
- C900301 PULSE OXIMETER SENSORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Pulse oximeter probe, single-use
LNCS Red TFA-1 by Masimo Corporation — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 084399700000Z1T1B04V106GF | Class IIb | Active |
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Manufacturer
- Manufacturer
- Masimo Corporation
- EUDAMED SRN
- US-MF-000010641
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED b348a6ce-2405-43e8-9267-33d189440571 61 fields · synced Jul 11, 2026