Transcutaneous Electrical Nerve Stimulator
by Wuxi Jiajian Medical Instrument Co., Ltd. 4 variants
Ref TENS EcoModel TENS Eco 2, TENS Eco, URO stim2, TENStem eco basic, TENS WMPS2-1,neurotech OmniTens XP+, neurotech PolyStim XP+, neurotech AvivaTens Plus
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697201171B2000001GS | Date13 May 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- TENS Eco 2, TENS Eco, URO stim2, TENStem eco basic, TENS WMPS2-1, neurotech OmniTens XP+, neurotech PolyStim XP+, neurotech AvivaTens Plus
- Primary DI / UDI-DI
- 06972011718134
- Basic UDI-DI
- 697201171B2000001GS
- Direct Marketing DI
- 06972011718134
- EMDN Code
- Z120622 Muscle stimulators
- Device Class
- Class IIa
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000012006
- Authorised representative
- Caretechion GmbH DE-AR-000005946
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Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No