Skip to content

E.M.S. Electro Medical Systems S.A. devices, product family

by E.M.S. Electro Medical Systems S.A.and 1 other manufacturer record 7 variants Basic UDI-DI 07613353042L6

Shared by every variant

Manufacturer
E.M.S. Electro Medical Systems S.A.(6)E.M.S. Electro Medical Systems S.A.(1)
Several manufacturer records share this Basic UDI-DI.
Basic UDI-DI
07613353042L6
Risk class
Class IIClass I (varies)
Legislation
MDR
EMDN category
TARTAR ABLATORS
Market status
7 on the market
Official record
EUDAMED public site — Open the EUDAMED public site, choose Devices, and search for the Basic UDI-DI 07613353042L6.

Recalls

3 recalls · 3 ongoing · FDA

  • Z-1686-2024 Class II · ongoing · 13 Mar 2024
    Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles).
  • Z-1687-2024 Class II · ongoing · 13 Mar 2024
    Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles).
  • Z-1688-2024 Class II · ongoing · 13 Mar 2024
    Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles).

Recalls matched to the 7 devices listed on this page; other pages of the family can carry others.

Variants

7 devices · page 1 of 1

Variants of E.M.S. Electro Medical Systems S.A. devices, Basic UDI-DI 07613353042L6
UDI-DISize and differences
AIR-FLOW-PIEZON EK-410A
E.M.S. Electro Medical Systems S.A.
EK-410A07613353123000
Prescription: yes
On the market
Boost wireless pedal EK-404B
E.M.S. Electro Medical Systems S.A.
EK-404B/D / EK-404B07613353311896
Prescription: yes
On the market
GBT Machine Wireless Pedal EK-1055B
E.M.S. Electro Medical Systems S.A.
EK-1055B07613353331184
Prescription: no
On the market
Multifunction foot pedal
E.M.S. Electro Medical Systems S.A.
EK-169#07613353239138 —On the market
PIEZON
E.M.S. Electro Medical Systems S.A.
EK-091 / E07613353191658
Prescription: yes
On the market
PIEZON c
E.M.S. Electro Medical Systems S.A.
EK-128 / c07613353002350
Prescription: yes
On the market
PIEZON g
E.M.S. Electro Medical Systems S.A.
EH-004 / g07613353056674
Prescription: yes
On the market