Identity
- Trade Name
- Elle TENS 2 EUDAMED
- Model / Reference
- ELLE TENS 2 EUDAMEDD-BC138T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060079211788 EUDAMED
- Basic UDI-DI
- B-05060079211788 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 2 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-05060079211788 | 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 624940b3-f176-4cbc-8636-21ac8cd1e183 61 fields · synced Jul 9, 2026