Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Patient monitoring system module, multiple-gas FDA UDI
- Device Name
- E-sCAiOV EUDAMEDE-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE, N-CAiO EUDAMEDE-SCAIOV-00, MODULE ASSEMBLY FDA UDI
- Model / Reference
- E-sCAiOV-00 EUDAMEDFDA UDI
- Description
- E-SCAIOV-00, MODULE ASSEMBLY FDA UDI
Identifiers
- Catalog Number
- E-sCAiOV-00 FDA UDI
- Primary DI / UDI-DI
- 00840682104142 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00840682104142 EUDAMED08406821BUG004677L EUDAMED
- Direct Marketing DI
- 00840682104142 EUDAMED
- FDA Product Code
- CBR FDA UDINHP FDA UDIBZL FDA UDICBQ FDA UDICAP FDA UDINHO FDA UDICCK FDA UDICBS FDA UDIBZK FDA UDICCL FDA UDINHQ 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
- 868.1700 FDA UDI868.1500 FDA UDI868.1730 FDA UDI868.2600 FDA UDI868.1400 FDA UDI868.1620 FDA UDI868.1850 FDA UDI868.1720 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-sCAiOV 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-00840682104142 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-00840682104142 | 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 1a0c8636-5722-4132-89db-4d193bbe2b51 61 fields · synced Oct 7, 2026
- EUDAMED b673c069-cfb4-4a44-a2e4-930e726c1034 61 fields · synced May 18, 2026
- FDA UDI 5162a214-df54-46a4-863b-3177b9dc67d8 36 fields · synced May 30, 2026