Identity
- Trade Name
- TruSignal SpO2 FDA UDI
- Generic Name
- Electrode/transducer strap, reusable FDA UDI
- Device Name
- TruSignal Attachment Accessories EUDAMEDReplacement Foam Wrap Medium for TruSignal Sensitive Skin sensor, 24 pcs FDA UDI
- Model / Reference
- TS-RWM-24 EUDAMEDFDA UDI
- Description
- Replacement Foam Wrap Medium for TruSignal Sensitive Skin sensor, 24 pcs FDA UDI
Identifiers
- Catalog Number
- TS-RWM-24 FDA UDI
- Primary DI / UDI-DI
- 00840682147293 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
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: General-purpose multi-parameter bedside monitor
TruSignal Attachment Accessories by GE Healthcare Finland Oy — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
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 a30baaef-20d1-49c9-b0c6-90b6bdb86f44 61 fields · synced Jul 16, 2026
- FDA UDI 0199b303-3fe7-4c8d-8a1d-c4c93b4754ac 35 fields · synced May 30, 2026