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Battery
EUDAMEDFDA UDIClass I (EU MDR)
Ref P27003-20Model ATLAS STAND BATTERY, SAMSUNG
Identity
- Trade Name
- Battery EUDAMEDFDA UDI
- Generic Name
- Portable/mobile rechargeable battery pack FDA UDI
- Device Name
- ATLAS STAND BATTERY, SAMSUNG EUDAMEDDiagnostic Ultrasound System Accessory FDA UDI
- Model / Reference
- ATLAS STAND BATTERY, SAMSUNG EUDAMEDP27003-20 EUDAMEDFDA UDI
- Description
- Diagnostic Ultrasound System Accessory FDA UDI
Identifiers
- Catalog Number
- P27003 FDA UDI
- Primary DI / UDI-DI
- 00841517106485 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00841517106485 EUDAMED
- 510(k) Number
- K200964 FDA UDI
- FDA Product Code
- ITX FDA UDIIYN FDA UDIIYO FDA UDIOIJ 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
- 892.1570 FDA UDI892.1550 FDA UDI892.1560 FDA UDI
- 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Battery by Fujifilm Sonosite, Inc. — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00841517106485 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Fujifilm Sonosite, Inc.
- EUDAMED SRN
- US-MF-000001075
- Authorised Representative
- Fujifilm Sonosite B.V. NL-AR-000000046
Sources (2)
- EUDAMED beeff8fb-dfbb-4f31-b23f-83801aff9cfb 61 fields · synced Aug 1, 2026
- FDA UDI a3830507-54a7-421e-8716-8883d37fca30 36 fields · synced May 30, 2026