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Edan Instruments, Inc. devices, product family

by Edan Instruments, Inc.and 1 other manufacturer record 23 variants Basic UDI-DI 6944138UTOBC9

Shared by every variant

Manufacturer
Edan Instruments, Inc.(19)Edan Instruments,Inc.(4)
Several manufacturer records share this Basic UDI-DI.
Basic UDI-DI
6944138UTOBC9
Risk class
Class IIClass IIa (varies)
Legislation
MDR
EMDN category
ULTRASOUND PROBES – OTHER
Market status
23 on the market
Official record
EUDAMED public site — Open the EUDAMED public site, choose Devices, and search for the Basic UDI-DI 6944138UTOBC9.

Recalls

1 recall · 1 ongoing · FDA

  • Z-1141-2026 Class II · ongoing · 24 Oct 2025
    As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

Recalls matched to the 23 devices listed on this page; other pages of the family can carry others.

Variants

23 devices · page 1 of 1

Variants of Edan Instruments, Inc. devices, Basic UDI-DI 6944138UTOBC9
UDI-DISize and differences
2.0MHz
Edan Instruments, Inc.
2.0MHz06944413805538
Prescription: no
On the market
2MHz
Edan Instruments, Inc.
2MHz06944413805651
Prescription: no
On the market
2MHz
Edan Instruments, Inc.
2MHz06944413805583
Prescription: no
On the market
2MHz
Edan Instruments, Inc.
2MHz06944413805637
Prescription: no
On the market
3.0MHz
Edan Instruments, Inc.
3.0MHz06944413805545
Prescription: no
On the market
3MHz
Edan Instruments, Inc.
3MHz06944413805590
Prescription: no
On the market
3MHz
Edan Instruments, Inc.
3MHz06944413805644
Prescription: no
On the market
4.0MHz
Edan Instruments, Inc.
4.0MHz06944413805552
Prescription: no
On the market
4MHz
Edan Instruments, Inc.
4MHz06944413805606
Prescription: no
On the market
5.0MHz
Edan Instruments, Inc.
5.0MHz06944413805569
Prescription: no
On the market
5MHz
Edan Instruments, Inc.
5MHz06944413805613
Prescription: no
On the market
8.0MHz
Edan Instruments, Inc.
8.0MHz06944413805576
Prescription: no
On the market
8MHz
Edan Instruments, Inc.
8MHz06944413805620
Prescription: no
On the market
Ultrasonic Transducer
Edan Instruments,Inc.
BT6-US06944413836952 —On the market
Ultrasonic Transducer
Edan Instruments,Inc.
MS3-109301(C)06944413847040 —On the market
Ultrasonic Transducer
Edan Instruments,Inc.
US-T06944413805743 —On the market
Ultrasonic Transducer
Edan Instruments,Inc.
WT6-US06944413807211 —On the market
Ultrasound Transducer US-SAF
Edan Instruments, Inc.
US-SAF06944413812512
Prescription: yes
On the market
Ultrasound Transducer US-SF
Edan Instruments, Inc.
US-SF06944413812475
Prescription: yes
On the market
Ultrasound Transducer US-TAF
Edan Instruments, Inc.
US-TAF06944413812529
Prescription: yes
On the market
Ultrasound Transducer US-TF
Edan Instruments, Inc.
US-TF06944413812482
Prescription: yes
On the market
US Transducer 12 ultrasound crystals, 1MHz
Edan Instruments, Inc.
12 ultrasound crystals, 1MHz06944413805491
Prescription: yes
On the market
US Transducer 8 ultrasound crystals, 1MHz
Edan Instruments, Inc.
8 ultrasound crystals, 1MHz06944413805484
Prescription: yes
On the market