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Aisys CS2
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref 1011-9050-000510(k) K170872
Identity
- Trade Name
- Aisys CS2 EUDAMEDAisys FDA UDI
- Generic Name
- Anaesthesia workstation, general-purpose FDA UDI
- Device Name
- Aisys CS2 EUDAMEDFDA UDI
- Model / Reference
- 1011-9050-000 EUDAMEDCS2 FDA UDI
- Description
- AISYS CS2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682102292 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00840682102292 EUDAMED
- 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 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
Yes
EUDAMED
Measuring Function
No
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
Aisys CS2 by Datex-Ohmeda Inc. — Class IIb — FDA_510K, MDD — 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/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K170872 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-00840682102292 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Datex-Ohmeda Inc.
- EUDAMED SRN
- US-MF-000014656
- FDA Applicant
- Datex-Ohmeda, Inc.
- Authorised Representative
- GE Healthcare Finland Oy FI-AR-000017101
Sources (3)
- EUDAMED 037782ab-3065-4cbb-a38f-b6b2a4911f54 85 fields · synced Jun 18, 2026
- FDA UDI b59b02ee-c17e-4e53-8347-30496519ff06 36 fields · synced May 30, 2026
- FDA 510(k) K170872 1 fields · synced May 18, 2026