Identity
- Trade Name
- S3ESCLS EUDAMEDFDA UDI
- Generic Name
- Oesophageal ultrasound imaging transducer, reusable FDA UDI
- Device Name
- S3ESCLS EUDAMEDProbe FDA UDI
- Model / Reference
- 04573596212318 EUDAMEDS3ESCLS FDA UDI
- Description
- Probe FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04573596212318 EUDAMEDFDA UDI
- Basic UDI-DI
- 457359621S3ESCLSPQ EUDAMED
- Direct Marketing DI
- 04573596212318 EUDAMED
- FDA Product Code
- IYN FDA UDIITX FDA UDIIYO FDA UDI
- EMDN Code
- Z1104020301 TRANSESOPHAGEAL ULTRASOUND PROBES, TWO–DIMENSIONAL EUDAMED
- GMDN Term
- Oesophageal ultrasound imaging transducer, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1550 FDA UDI892.1570 FDA UDI892.1560 FDA UDI
- Market of Registration
- Netherlands 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
Category: Oesophageal ultrasound imaging transducer, reusable
S3escls by FUJIFILM Corporation — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Oesophageal ultrasound imaging transducer, reusable.
- V7M Transducer — SIEMENS MEDICAL SOLUTIONS USA, INC. · Class II
- TEEx/8-3 MHz — Fujifilm Sonosite, Inc. · Class II
- P8-2Ts Transducer(FDA-SJM) — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
- Z6Ms Transducer — SIEMENS MEDICAL SOLUTIONS USA, INC. · Class II
- Tee probe — CHISON Medical Technologies Co., Ltd. · Class II
- MULTI-PLANE TRANSESOPHAGEAL TRANSDUCER — Canon Medical Systems Corporation · Class II
- TEEx/8-3 MHz — Fujifilm Sonosite, Inc. · Class II
- Tee probe — CHISON Medical Technologies Co., Ltd. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- FUJIFILM Corporation
Sources (2)
- FDA UDI 88a06dd3-e689-4160-880b-cdbcbb0cae64 34 fields · synced Jun 18, 2026
- EUDAMED b2f0cb77-d370-4232-b92b-7017e351552d 61 fields · synced Jun 18, 2026