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EUDAMED last updated this device on Jul 7, 2026
69478325TMXX2024112700CKTENS/EMS Unit is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Shenzhen Aeon Technology Co., Ltd.. Placed on the EU market in Iceland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06947832500749A6211 packaging level registered — each level carries its own UDI-DI.
06947832500749× 1 unitBase unit56947832500744× 40 unitsNo longer placed on the market(01)06947832500749
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z12062801MUSCLE REINFORCEMENT STIMULATORS FOR INNERVATED MUSCLES1 warning recorded — scroll inside the panel to see all entries.
For the following people, use after consulting with a doctor (may cause discomfort). (1) Patients with cardiac demand pacemakers should not use this device. (2) Patients who are under medical treatment by a doctor and feel physically abnormal. (3) Patients with malignant tumors. (4) Patients with abnormalities of the heart, brain and nerves. (5) Pregnant women and women in labor. (6) Patients with body temperature over 38℃ (fever stage). (7) Patients with infectious diseases. (8) Patients with skin perception disorder or skin abnormality. (9) Patients with acute illnesses. (10) Patients who need to rest and recuperate. (11) Patients who are taking medication. (12) Patients with abnormal blood pressure. (13) Patients with bleeding tendency. (14) Patients who cannot express their will freely. (15) Patients with peripheral circulatory disorders due to diabetes mellitus, etc. (16) Patients whose skin is allergic to electrodes. (17) Do not use the same area for a long time (more than 40 minutes), no more than 3 ti
CN-MF-000012690The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Primary placement in Iceland; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| IcelandPrimary placement | — | Still on market |
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
View in glossary →Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
View in glossary →Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
View in glossary →CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
View in glossary →Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →MDR risk classes
MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →69478325TMXX2024112700CKOn the marketTENS/EMS Unit69478325TMXX2024112700CKOn the marketTENS/EMS Unit69478325TMXX2024112700CKOn the marketTENS/EMS Unit69478325TMXX2024112700CKOn the marketTENS/EMS UnIT69478325TMXX2024112700CKOn the marketTENS/EMS UnIT69478325TMXX2024112700CKOn the marketNo certificate specifically references this device's Basic UDI-DI.
Certificate health across this manufacturer's portfolio.
G15 073767 0021SupplementedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →