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TENS/EMS Unit
EUDAMEDClass IIa (EU MDR)
Ref A621Model A620, A621, A622, A620P, A621P, A622P, A620W, A621W, A622W
Identity
- Trade Name
- TENS/EMS Unit EUDAMED
- Device Name
- TENS/EMS Unit EUDAMED
- Model / Reference
- A620, A621, A622, A620P, A621P, A622P, A620W, A621W, A622W EUDAMEDA621 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06947832500749 EUDAMED
- Basic UDI-DI
- 69478325TMXX2024112700CK EUDAMED
- Direct Marketing DI
- 06947832500749 EUDAMED
- EMDN Code
- Z12062801 MUSCLE REINFORCEMENT STIMULATORS FOR INNERVATED MUSCLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Iceland 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 (1)
- EUDAMED 705c5aed-8622-4675-b15f-461eb8294c9a 61 fields · synced Jun 18, 2026