Identity
- Trade Name
- Portrait SpO2 P-W01 EUDAMEDFDA UDI
- Generic Name
- Pulse oximeter probe/processor FDA UDI
- Device Name
- Portrait Wearable Pulse Oximetry Sensors EUDAMEDPORTRAIT SpO2 P-W FINAL DEVICE ASSEMBLY FDA UDI
- Model / Reference
- 2096441-001 EUDAMEDP-W01 FDA UDI
- Description
- PORTRAIT SpO2 P-W FINAL DEVICE ASSEMBLY FDA UDI
Identifiers
- Catalog Number
- 2096441-001 FDA UDI
- Primary DI / UDI-DI
- 00195278264800 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00260H8 EUDAMED
- Direct Marketing DI
- 00195278264800 EUDAMED
- 510(k) Number
- K230626 FDA UDI
- FDA Product Code
- DQA FDA UDIMSX FDA UDIBZQ FDA UDIMWI FDA UDIDRG FDA UDI
- EMDN Code
- Z1203020280 MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Pulse oximeter probe/processor FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2700 FDA UDI870.2300 FDA UDI868.2375 FDA UDI870.2910 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Portrait SpO2 P-W01 by GE Healthcare Finland Oy — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8406821BUG00260H8 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- GE Healthcare Finland Oy
- EUDAMED SRN
- FI-MF-000001176
Sources (2)
- EUDAMED eeeee6fe-f085-40a6-8578-582e1e0773ab 61 fields · synced Oct 6, 2026
- FDA UDI 498ae565-8b4c-4386-9eb0-cf50ae55e8a5 36 fields · synced May 30, 2026