Transcutaneous Electrical Nerve Stimulator
by Shenzhen Kentro Medical Electronics CO., LTD.
Ref Z12062801
Active
CE MDR
Valid until
20 Nov 2027
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number28620156612-01 | Date4 Jun 2025 | StatusActive |
Certificates
- 28620156612-01 Active
Quality management system EU MDR
- Certifier
- Intertek Medical Notified Body AB 2862
- Issued
- 4 Jun 2025
- Expires
- 20 Nov 2027
- Reason
- Ar data change
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Transcutaneous Electrical Nerve Stimulators
- Model / Reference
- Z12062801
- Primary DI / UDI-DI
- 06924607703642, 06924607703482, 06924607703567, 06924607703734, 06924607703659, 06924607703505
- Basic UDI-DI
- 69246077022497B
- EMDN Code
- Z12062801 Muscle reinforcement stimulators for innervated muscles
- Device Class
- Class IIa
- EU market of registration
- PolandGermanySpainNorway
Manufacturer details
- EUDAMED SRN
- CN-MF-000011247
- Authorised representative
- Share info GmbH DE-AR-000005132
Other devices from Shenzhen Kentro Medical Electronics Co., Ltd
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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