Electronic Muscle Stimulator
by Shenzhen OSTO Medical Technology Company Limited China EUDAMED
Ref AST-300N EMDN Z12062801
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number695094080001GT | Date26 Dec 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Electronic Muscle Stimulator
- Model / Reference
- AST-300N
- Primary DI / UDI-DI
- 06950940802643, 06950940802629
- Basic UDI-DI
- 695094080001GT
- EMDN Code
- Z12062801 Muscle reinforcement stimulators for innervated muscles
- Device Class
- Class IIa
- Market of Registration
- Northern Ireland
Manufacturer details
- EUDAMED SRN
- CN-MF-000022960
- Authorised representative
- phoenix Medtech GmbH DE-AR-000007996
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Properties & raw data
Show properties, registry sources and raw records
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
Sources (2)
- EUDAMED c3493483-fe7f-4b62-af71-e3e779fce8d4
- EUDAMED 06950940802629|695094080001GT