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Carestation 650c A1
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref 1012-9655-200Model Carestation 620 A1, Carestation 650 A1, Carestation 650c A1Ref 1012-9655-000
Identity
- Trade Name
- Carestation 650c A1 EUDAMEDCarestation 650c FDA UDI
- Generic Name
- Anaesthesia workstation, general-purpose FDA UDI
- Device Name
- Anesthesia System EUDAMED
- Model / Reference
- Carestation 620 A1, Carestation 650 A1, Carestation 650c A1 EUDAMED1012-9655-200 EUDAMED1012-9655-000 EUDAMEDA1 FDA UDI
Identifiers
- Catalog Number
- 1012-9655-000 FDA UDI
- Primary DI / UDI-DI
- 00195278439543 EUDAMED00840682103954 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00403H6 EUDAMED8406821BUG00168HK EUDAMED
- 510(k) Number
- K151570 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 650c A1 by Datex-Ohmeda Inc. — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K151570 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 8406821BUG00403H6 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Datex-Ohmeda Inc.
- EUDAMED SRN
- US-MF-000014656
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (4)
- EUDAMED 6ed4568a-d9be-4249-926a-816308c4a2c6 61 fields · synced Aug 1, 2026
- EUDAMED 77623af8-4176-43e9-8d35-558162d3d0a1 61 fields · synced May 17, 2026
- FDA UDI 1bb918c3-494b-40b6-9ff8-0648e1e81d7a 36 fields · synced May 30, 2026
- FDA 510(k) K151570 1 fields · synced May 18, 2026