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actiTENS mini cables – 100 cm
EUDAMEDClass I (EU MDR)
Ref SBM7AE003Model 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 – 100 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 EUDAMEDSBM7AE003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978035540027 EUDAMED
- Basic UDI-DI
- 697803554TLW001S9 EUDAMED
- EMDN Code
- Z12039080 VARIOUS INSTRUMENTS TO SUPPORT AND MONITOR VITAL SIGNS - HARDWARE ACCESSORIES 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 – 100 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 c8c12525-ddaa-4790-8eb8-2bf7e17fbf96 61 fields · synced Oct 6, 2026