Identity
- Trade Name
- Kosmos Link EUDAMEDFDA UDIKosmos Link [Refurbished] EUDAMED
- Generic Name
- Portable/mobile rechargeable battery pack FDA UDI
- Device Name
- Kosmos Class I Accessories EUDAMEDKosmos Link FDA UDI
- Model / Reference
- P008392 EUDAMEDFDA UDIR008392 EUDAMED
- Description
- Kosmos Link FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09353278000809 EUDAMED09353278000854 EUDAMEDFDA UDI
- Basic UDI-DI
- 93532780AIStation2U3 EUDAMED
- FDA Product Code
- IYN FDA UDIIYO FDA UDIITX FDA UDIDQD FDA UDIDPS FDA UDIQIH FDA UDI
- EMDN Code
- Z1104018099 ULTRASOUND SCANNERS – HARDWARE ACCESSORIES – OTHER EUDAMED
- GMDN Term
- Portable/mobile rechargeable battery pack FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1550 FDA UDI892.1560 FDA UDI892.1570 FDA UDI870.1875 FDA UDI870.2340 FDA UDI892.2050 FDA UDI
- Market of Registration
- Denmark EUDAMED
- Commercial Distribution
- Not 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Kosmos Link 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 |
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Manufacturer
- Manufacturer
- EchoNous
- EUDAMED SRN
- US-MF-000004161
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (3)
- EUDAMED 65e40ab9-6028-476d-b7b4-5b677e3c5bd9 61 fields · synced Jul 16, 2026
- EUDAMED 593a3514-245b-41d2-9c8e-0d297977c78d 61 fields · synced May 16, 2026
- FDA UDI bcaaa3d9-5bd1-42f9-a4d6-fb1d7d41ab5b 34 fields · synced May 29, 2026