Electronic Muscle Stimulator
by Shenzhen OSTO Medical Technology Company Limited 25 variants
Ref AST-105E
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 | Number695094080001GT 06950940802872 | Date26 Dec 2024 | 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- Withdrawn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
- Device Name
- Electronic Muscle Stimulator
- Model / Reference
- AST-105E
- Primary DI / UDI-DI
- 06950940802872
- Basic UDI-DI
- 695094080001GT
- EMDN Code
- Z12062801 Muscle reinforcement stimulators for innervated muscles
- Device Class
- Class IIa
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000022960
- Authorised representative
- phoenix Medtech GmbH DE-AR-000007996
Other devices from Shenzhen OSTO Medical Technology Company Limited
See all devices from Shenzhen OSTO Medical Technology Company Limited →
Properties
Other properties (12)
- Sterile: No
- Implantable: 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