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E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE, N-CA…
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref E-sCAiOVE-00
Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Patient monitoring system module, multiple-gas FDA UDI
- Device Name
- E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE, N-CAiO EUDAMEDE-sCAiOVE EUDAMEDE-SCAIOVE-00, MODULE ASSEMBLY FDA UDI
- Model / Reference
- E-sCAiOVE-00 EUDAMEDFDA UDI
- Description
- E-SCAIOVE-00, MODULE ASSEMBLY FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682104302 EUDAMEDFDA UDI
- Basic UDI-DI
- 08406821BUG004677L EUDAMEDB-00840682104302 EUDAMED
- Direct Marketing DI
- 00840682104302 EUDAMED
- 510(k) Number
- K211171 FDA UDI
- FDA Product Code
- CBR FDA UDINHO FDA UDICAP FDA UDICCL FDA UDIBZK FDA UDICCK FDA UDINHQ FDA UDINHP FDA UDICBS FDA UDICBQ FDA UDIBZL 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 UDI868.2600 FDA UDI868.1720 FDA UDI868.1850 FDA UDI868.1400 FDA UDI868.1620 FDA UDI868.1730 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-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE, N-CA… by GE Healthcare Finland Oy — Class IIb — MDR, MDD, FDA UDI — listed in…
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 | 08406821BUG004677L | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | 08406821BUG004677L | 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 89907920-26a3-4ff8-a11a-9c1f55c22641 61 fields · synced Oct 7, 2026
- FDA UDI fbeed9ee-8394-4c80-a505-d13ac8064bcf 36 fields · synced May 30, 2026
- EUDAMED 51c22189-8846-466c-ab83-00c7b4ebaef6 61 fields · synced Jul 14, 2026