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Carestation 750 A1
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 1012-9750-000Model Carestation 750 & Carestation 750cModel Carestation 750
Identity
- Trade Name
- Carestation 750 A1 EUDAMEDCarestation 750 FDA UDI
- Generic Name
- Anaesthesia workstation, general-purpose FDA UDI
- Device Name
- Carestation 750 & Carestation 750c EUDAMEDAnesthesia System EUDAMEDCARESTATION 750 A1 FDA UDI
- Model / Reference
- Carestation 750 & Carestation 750c EUDAMED1012-9750-000 EUDAMEDCarestation 750 EUDAMEDA1 FDA UDI
- Description
- CARESTATION 750 A1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682145596 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00345HH EUDAMEDB-00840682145596 EUDAMED
- 510(k) Number
- K213867 FDA UDI
- FDA Product Code
- BSZ FDA UDI
- EMDN Code
- Z1203010101 ANAESTHESIA DEVICES EUDAMED
- GMDN Term
- Anaesthesia workstation, general-purpose FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5160 FDA UDI
- Market of Registration
- Finland EUDAMEDFrance 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
Yes
EUDAMED
Measuring Function
No
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
Carestation 750 A1 by Datex-Ohmeda Inc. — 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 | 8406821BUG00345HH | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | 8406821BUG00345HH | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Datex-Ohmeda Inc.
- EUDAMED SRN
- US-MF-000014656
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (3)
- EUDAMED 56f22777-0a05-41e7-a02f-b7148c37d73e 61 fields · synced Jul 29, 2026
- EUDAMED 2371e02b-835d-4159-9a8b-a33dd4a645fd 61 fields · synced May 17, 2026
- FDA UDI 7d508d00-53dc-406d-9b52-96ae716fd137 35 fields · synced May 30, 2026