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Battery
EUDAMEDClass I (EU MDR)
Ref P31541-02Model BATTERY PACK ASSEMBLYRef P31052-02Ref P31541-01Ref P31052-01Ref P31138-02Model SONOSITE PX ULTRASOUND SYSTEMRef P31051-01Model ATLAS STAND BATTERY, MOLICELRef P30416-05
Identity
- Trade Name
- Battery EUDAMED
- Device Name
- BATTERY PACK ASSEMBLY EUDAMEDSONOSITE PX ULTRASOUND SYSTEM EUDAMEDATLAS STAND BATTERY, MOLICEL EUDAMED
- Model / Reference
- BATTERY PACK ASSEMBLY EUDAMEDP31541-02 EUDAMEDP31052-02 EUDAMEDP31541-01 EUDAMEDP31052-01 EUDAMEDSONOSITE PX ULTRASOUND SYSTEM EUDAMEDP31138-02 EUDAMEDATLAS STAND BATTERY, MOLICEL EUDAMEDP31051-01 EUDAMEDP30416-05 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00841517111618 EUDAMED00841517111625 EUDAMED00841517107857 EUDAMED00841517107727 EUDAMED00841517111519 EUDAMED00841517107734 EUDAMED00841517111465 EUDAMED
- Basic UDI-DI
- 08415171BTRYKW EUDAMED08415171PX8P EUDAMEDB-00841517107734 EUDAMED
- EMDN Code
- Z1104018099 ULTRASOUND SCANNERS – HARDWARE ACCESSORIES – OTHER EUDAMEDZ11040103 PORTABLE ULTRASOUND SCANNERS EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass IIa EUDAMED
- Market of Registration
- Austria EUDAMEDItaly EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Battery by Fujifilm Sonosite, Inc. — Class I — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 08415171BTRYKW | Class I | Active |
| EUDAMED | European Union | CE/MDR | 08415171BTRYKW | Class I | Active |
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Manufacturer
- Manufacturer
- Fujifilm Sonosite, Inc.
- EUDAMED SRN
- US-MF-000001075
- Authorised Representative
- Fujifilm Sonosite B.V. NL-AR-000000046
Sources (7)
- EUDAMED 6982f6e7-42bb-4ad6-a17d-f360044a58b3 61 fields · synced Jul 29, 2026
- EUDAMED bc50dd61-bcb5-4aa5-80ea-68c5d677a924 61 fields · synced May 16, 2026
- EUDAMED 1e359a28-7fdc-4ba7-abd4-136a5396cd03 61 fields · synced May 17, 2026
- EUDAMED be573d51-86cb-4989-b47d-70eba241dced 61 fields · synced May 17, 2026
- EUDAMED 42b898b7-d2ed-446b-83dd-28e43fef20a3 61 fields · synced May 18, 2026
- EUDAMED 53aeb5ad-e8a1-4689-b333-23ea1af030aa 61 fields · synced May 18, 2026
- EUDAMED d8dca610-fa75-427b-b1ef-6638fceeee18 61 fields · synced May 18, 2026