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actiTENS mini cables – 14 cm
EUDAMEDClass I (EU MDR)
Ref SBM7AE002Model SBM7AE001,SBM7AE002,SBM7AE003,SBM7AE004,8704423,8704424,8704437,962SU-24090202,962SU-24090203,962SU-24090204,962SU-24090205,695BT-24050501,695BT-24050502,GC06033001
Identity
- Trade Name
- actiTENS mini cables – 14 cm EUDAMED
- Device Name
- Tens Lead wire EUDAMED
- Model / Reference
- SBM7AE001,SBM7AE002,SBM7AE003,SBM7AE004,8704423,8704424,8704437,962SU-24090202,962SU-24090203,962SU-24090204,962SU-24090205,695BT-24050501,695BT-24050502,GC06033001 EUDAMEDSBM7AE002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978035540010 EUDAMED
- Basic UDI-DI
- 697803554TLW001S9 EUDAMED
- EMDN Code
- Z12030680 EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
actiTENS mini cables – 14 cm by Dongguan Goochain Technology Co., Ltd — Class I — 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 | 697803554TLW001S9 | Class I | Active |
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Manufacturer
- Manufacturer
- Dongguan Goochain Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000045464
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 97d5b46d-aeed-4efa-92c5-d0168c946976 61 fields · synced Oct 6, 2026