Identity
- Trade Name
- CARESCAPE EUDAMEDCARESCAPE B850 FDA UDI
- Generic Name
- General-purpose multi-parameter bedside monitor FDA UDI
- Device Name
- CARESCAPE B850 EUDAMEDCARESCAPE B850 MBC313 (ATO MODEL) FDA UDI
- Model / Reference
- MBC313 EUDAMEDFDA UDI5514366 EUDAMED
- Description
- CARESCAPE B850 MBC313 (ATO MODEL) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682144308 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00840682144308 EUDAMED
- 510(k) Number
- K191323 FDA UDI
- FDA Product Code
- ORT FDA UDIFLL FDA UDIDSK FDA UDICCL FDA UDIDRT FDA UDIMLD FDA UDINHQ FDA UDIBZL FDA UDIDPZ FDA UDIDSI FDA UDIOMC FDA UDIDQK FDA UDICAP FDA UDIDQA FDA UDIMHX FDA UDIDXN FDA UDICBR FDA UDICBS FDA UDIKRB FDA UDICBQ FDA UDIBZK FDA UDIDSJ FDA UDIBZQ FDA UDINHP FDA UDIOLT FDA UDIDXG FDA UDIGWJ FDA UDICCK FDA UDIKOI FDA UDIDPS FDA UDINHO FDA UDIOLW FDA UDIGWQ FDA UDI
- EMDN Code
- Z1203020201 MULTI–PARAMETER PATIENT BEDSIDE MONITORS EUDAMED
- GMDN Term
- General-purpose multi-parameter bedside monitor FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1400 FDA UDI880.2910 FDA UDI870.1110 FDA UDI868.1720 FDA UDI870.2300 FDA UDI870.1025 FDA UDI868.1500 FDA UDI868.1730 FDA UDI870.2710 FDA UDI870.1425 FDA UDI868.2600 FDA UDI870.2700 FDA UDI870.1130 FDA UDI868.1700 FDA UDI868.1620 FDA UDI870.1915 FDA UDI868.1850 FDA UDI870.1100 FDA UDI868.2375 FDA UDI870.1435 FDA UDI882.1900 FDA UDI868.1400 FDA UDI868.2775 FDA UDI870.2340 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Carescape by GE Healthcare Finland Oy — Class IIb — MDD, 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-00840682144308 | 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 (2)
- EUDAMED b6036528-2752-41f4-8bfb-9b6cf3056fa8 61 fields · synced Jun 15, 2026
- FDA UDI b88417a2-0f6d-4a1c-8709-acc8beaa22a4 36 fields · synced May 30, 2026