Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Patient monitoring system module, pulse oximetry FDA UDI
- Device Name
- E-NSATX EUDAMED
- Model / Reference
- E-NSATX-00 EUDAMEDFDA UDIE-NSATX-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840682104265 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00840682104265 EUDAMED8406821BUG00435HK EUDAMED
- 510(k) Number
- K052755 FDA UDI
- FDA Product Code
- DPZ FDA UDIDQA FDA UDI
- EMDN Code
- Z1203020280 MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Patient monitoring system module, pulse oximetry FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2710 FDA UDI870.2700 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
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
Yes
FDA UDI
MR Unsafe FDA UDI
E-Nsatx by GE Healthcare Finland Oy — Class IIb — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-00840682104265 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-00840682104265 | 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 (3)
- EUDAMED d53cc27b-c1d9-4b21-b2a6-15530bd31dd3 61 fields · synced Oct 7, 2026
- EUDAMED 1c8272ae-fd0a-4096-980f-f842bbf513c1 61 fields · synced May 17, 2026
- FDA UDI 472951d2-431b-44fe-a987-aaea06137c02 35 fields · synced May 30, 2026