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E-Masimo
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref E-MASIMO-00Ref M1121204Model E-MASIMO-00
Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Patient monitoring system module, pulse oximetry FDA UDI
- Device Name
- E-MASIMO EUDAMEDE-MASIMO-00 EUDAMED
- Model / Reference
- E-MASIMO-00 EUDAMEDFDA UDIM1121204 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840682104203 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00434HH EUDAMEDB-00840682104203 EUDAMED
- 510(k) Number
- K081870 FDA UDI
- FDA Product Code
- DQA 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
- 870.2700 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-Masimo by GE Healthcare Finland Oy — Class IIb — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 8406821BUG00434HH | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 8406821BUG00434HH | 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 a308dcd5-bb74-4459-ad3f-c37f74cb1cc2 61 fields · synced Oct 6, 2026
- EUDAMED 6f73d8f0-61ee-43cd-89bc-bb586cb91922 61 fields · synced May 17, 2026
- FDA UDI 117cecf9-e324-469c-8429-609fce1da46e 35 fields · synced May 30, 2026