Identity
- Trade Name
- AI Station 2 EUDAMEDFDA UDI
- Generic Name
- Radiological imaging system transport kit FDA UDI
- Device Name
- Kosmos Class I Accessories EUDAMEDRadiological imaging system transport kit FDA UDI
- Model / Reference
- P006200 EUDAMEDFDA UDI
- Description
- Radiological imaging system transport kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09353278000229 EUDAMEDFDA UDI
- Basic UDI-DI
- 93532780AIStation2U3 EUDAMED
- Direct Marketing DI
- 09353278000229 EUDAMED
- FDA Product Code
- IYO FDA UDIIYN FDA UDI
- EMDN Code
- Z1104018099 ULTRASOUND SCANNERS – HARDWARE ACCESSORIES – OTHER EUDAMED
- GMDN Term
- Radiological imaging system transport kit FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1560 FDA UDI892.1550 FDA UDI
- Market of Registration
- Denmark 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
AI Station 2 by EchoNous — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 93532780AIStation2U3 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- EchoNous
- EUDAMED SRN
- US-MF-000004161
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 65dd78ce-dde8-432d-a9ca-f24ae0ceef7f 61 fields · synced Jul 17, 2026
- FDA UDI 8563c1fe-0dc5-4923-84c1-92bcbafd1cb3 34 fields · synced May 30, 2026