Identity
- Trade Name
- TruSignal SpO2 FDA UDI
- Generic Name
- Electrode/transducer strap, reusable FDA UDI
- Device Name
- TruSignal Attachment Accessories EUDAMEDInfant Foam Sandal Wrap for TruSignal Sensitive Skin sensor, 3 pcs FDA UDI
- Model / Reference
- TS-SND-3 EUDAMEDFDA UDI
- Description
- Infant Foam Sandal Wrap for TruSignal Sensitive Skin sensor, 3 pcs FDA UDI
Identifiers
- Catalog Number
- TS-SND-3 FDA UDI
- Primary DI / UDI-DI
- 00840682147248 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00052GX EUDAMED
- 510(k) Number
- K093881 FDA UDI
- FDA Product Code
- DPZ FDA UDI
- EMDN Code
- Z1203020285 MULTI-PARAMETER MONITORS - CONSUMABLES EUDAMED
- GMDN Term
- Electrode/transducer strap, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2710 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
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
TruSignal Attachment Accessories by GE Healthcare Finland Oy — Class I — 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 | 8406821BUG00052GX | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- GE Healthcare Finland Oy
- EUDAMED SRN
- FI-MF-000001176
Sources (2)
- EUDAMED 82adf995-ebcd-4c01-a9ff-62815988ce2f 61 fields · synced Oct 6, 2026
- FDA UDI c8d30a50-c9d7-4487-b3da-00370875a298 35 fields · synced May 30, 2026