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TruSignal SpO2 Resusable Sensor, Finger, Adult, 1M
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref TS-SA-D
Identity
- Trade Name
- TruSignal SpO2 FDA UDI
- Generic Name
- Pulse oximeter, line-powered FDA UDI
- Device Name
- TruSignal SpO2 Resusable Sensor, Finger, Adult, 1M EUDAMED
- Model / Reference
- TS-SA-D EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682103329 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00840682103329 EUDAMED
- 510(k) Number
- K101871 FDA UDI
- FDA Product Code
- DQA FDA UDI
- EMDN Code
- Z1203020280 MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Pulse oximeter, line-powered FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2700 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
TruSignal SpO2 Resusable Sensor, Finger, Adult, 1M by GE Healthcare Finland Oy — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00840682103329 | 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 746993b0-2872-4f53-b522-d591a6db4a80 61 fields · synced Oct 6, 2026
- FDA UDI 0c46041e-40bc-4337-9b79-1f5e82e82738 35 fields · synced May 27, 2026