Identity
- Trade Name
- Elle TENS Plus EUDAMED
- Model / Reference
- Elle TENS Plus EUDAMEDD-BC09T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060079211313 EUDAMED
- Basic UDI-DI
- B-05060079211313 EUDAMED
- EMDN Code
- Z12062780 FUNCTIONAL ELECTRICAL STIMULATION SYSTEMS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Elle TENS Plus by Body Clock Health Care Limited — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05060079211313 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Body Clock Health Care Limited
- EUDAMED SRN
- GB-MF-000007381
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (1)
- EUDAMED a3c6187f-4730-4860-9e26-5c62f57ee3bf 61 fields · synced Jun 17, 2026