Identity
- Trade Name
- Kosmos Power Pack EUDAMEDFDA UDI
- Generic Name
- Portable/mobile rechargeable battery pack FDA UDI
- Device Name
- Kosmos Class I Accessories EUDAMEDKosmos Power Pack FDA UDI
- Model / Reference
- P007640 EUDAMEDFDA UDI
- Description
- Kosmos Power Pack FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09353278000632 EUDAMEDFDA UDI
- Basic UDI-DI
- 93532780AIStation2U3 EUDAMED
- Direct Marketing DI
- 09353278000632 EUDAMED
- 510(k) Number
- K212100 FDA UDI
- FDA Product Code
- IYN 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 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
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
Kosmos Power Pack 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 776c3537-6e59-45e1-bdac-8a06dd75de2f 61 fields · synced Jul 20, 2026
- FDA UDI de984bfc-375a-46a2-a2ac-b76d2ca3807b 34 fields · synced May 30, 2026