Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Patient monitoring system module, multiple-gas FDA UDI
- Device Name
- E-sCAiOE EUDAMEDE-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE, N-CAiO EUDAMEDE-SCAIOE-00, MODULE ASSEMBLY FDA UDI
- Model / Reference
- E-sCAiOE-00 EUDAMEDFDA UDI
- Description
- E-SCAIOE-00, MODULE ASSEMBLY FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682104135 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00840682104135 EUDAMED08406821BUG004677L EUDAMED
- Direct Marketing DI
- 00840682104135 EUDAMED
- 510(k) Number
- K211171 FDA UDI
- FDA Product Code
- NHP FDA UDINHQ FDA UDINHO FDA UDICBS FDA UDIBZK FDA UDICAP FDA UDICBR FDA UDICBQ FDA UDIBZL FDA UDICCK FDA UDI
- EMDN Code
- Z1203020280 MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Patient monitoring system module, multiple-gas FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 868.1500 FDA UDI868.1620 FDA UDI868.1850 FDA UDI868.2600 FDA UDI868.1700 FDA UDI868.1730 FDA UDI868.1400 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
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
E-sCAiOE by GE Healthcare Finland Oy — Class IIb — CE/MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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-00840682104135 | 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 6ed91648-50c1-4fe6-8bf3-be4ff12d12fb 61 fields · synced Oct 7, 2026
- FDA UDI 2bc47552-ab64-4fd1-8946-9e3c74085b5a 35 fields · synced May 30, 2026
- EUDAMED 28ff4c48-3c44-4ade-9bb4-557640dbc5d6 61 fields · synced Jul 9, 2026