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TENS/EMS Unit
EUDAMEDClass IIa (EU MDR)
Ref A620Model A620, A621, A622, A620P, A621P, A622P, A620W, A621W, A622WRef A620WRef A622WRef A621WRef A622
Identity
- Trade Name
- TENS/EMS Unit EUDAMED
- Device Name
- TENS/EMS Unit EUDAMED
- Model / Reference
- A620, A621, A622, A620P, A621P, A622P, A620W, A621W, A622W EUDAMEDA620 EUDAMEDA620W EUDAMEDA622W EUDAMEDA621W EUDAMEDA622 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06947832500732 EUDAMED06947832500831 EUDAMED06947832500855 EUDAMED06947832500848 EUDAMED06947832500756 EUDAMED
- Basic UDI-DI
- 69478325TMXX2024112700CK EUDAMED
- Direct Marketing DI
- 06947832500732 EUDAMED06947832500831 EUDAMED06947832500855 EUDAMED06947832500848 EUDAMED06947832500756 EUDAMED
- EMDN Code
- Z12062801 MUSCLE REINFORCEMENT STIMULATORS FOR INNERVATED MUSCLES EUDAMEDZ12159085 VARIOUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland EUDAMEDIreland EUDAMEDSpain EUDAMEDItaly 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
TENS/EMS Unit by Shenzhen Aeon Technology Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 69478325TMXX2024112700CK | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Aeon Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000012690
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (5)
- EUDAMED 175dcf33-4f07-46f8-8b32-c02aeeb34538 61 fields · synced Jul 20, 2026
- EUDAMED 978af8f2-da87-4297-8e2c-5e5efd040124 61 fields · synced May 17, 2026
- EUDAMED e7f21947-32e7-4f2b-a302-050bcde5f55a 61 fields · synced May 17, 2026
- EUDAMED f71b673c-a07c-4d1d-9017-f99c4b120f59 61 fields · synced May 18, 2026
- EUDAMED 19eb81e1-f6a7-4579-9709-2da50149a9f9 61 fields · synced May 18, 2026