← Back to catalogue
HFL50x/15-6 MHz
EUDAMEDClass IIa (EU MDR)
Ref P24536-02Model TRANSDUCER, HFL50X/15-6 MHZ
Identity
- Trade Name
- HFL50x/15-6 MHz EUDAMED
- Device Name
- TRANSDUCER, HFL50X/15-6 MHZ EUDAMED
- Model / Reference
- TRANSDUCER, HFL50X/15-6 MHZ EUDAMEDP24536-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00841517111021 EUDAMED
- Basic UDI-DI
- 08415171HFL50X85 EUDAMED
- EMDN Code
- Z110402010101 TWO–DIMENSIONAL LINEAR–ARRAY TRANSCUTANEOUS ULTRASOUND PROBES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Denmark 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
Category: Extracorporeal ultrasound imaging transducer, hand-held
HFL50x/15-6 MHz by Fujifilm Sonosite, Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Extracorporeal ultrasound imaging transducer, hand-held.
- 6C2 Transducer — SIEMENS MEDICAL SOLUTIONS USA, INC. · Class II
- Biim Android App, P1.3 — Biim Ultrasound AS · Class II
- C6-2 Transducer — SIEMENS MEDICAL SOLUTIONS USA, INC. · Class II
- Battery Charger AU, Biim Ultrasound — Biim Ultrasound AS · Class II
- SonoScape — SONOSCAPE MEDICAL CORP. · Class II
- 4C1 Transducer — SIEMENS MEDICAL SOLUTIONS USA, INC. · Class II
- UST-5419 — FUJIFILM Corporation · Class II
- P4-12 — SAMSUNG MEDISON CO., LTD · Class II
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08415171HFL50X85 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fujifilm Sonosite, Inc.
- EUDAMED SRN
- US-MF-000001075
- Authorised Representative
- Fujifilm Sonosite B.V. NL-AR-000000046
Sources (1)
- EUDAMED c7759e57-5c77-44ab-a141-49a1aff2ce88 61 fields · synced Jun 19, 2026