Self Therapy
by Bio Brem SA Switzerland EUDAMED
Ref STSLF01, STPCK01Model Self Therapy
EMDN Z120606
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number7649989552Self_TherapyMB | Date17 Jan 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- 0425-MDR-030113-00 Suspended
Quality assurance EU MDR
- Notified body
- ICIM S.P.A. 0425
- Issued
- 20 Dec 2024
- Expires
- 19 Dec 2029
- Reason
- Failure contractual obligations
Specification
- Trade Name
- Self TherapySelf Therapy Pocket
- Model / Reference
- Self Therapy, STSLF01, STPCK01
- Primary DI / UDI-DI
- 07649989552013, 07649989552020
- Basic UDI-DI
- 7649989552Self_TherapyMB
- Direct Marketing DI
- 0764998955201307649989552020
- EMDN Code
- Z120606 Magnetotherapy equipment
- Device Class
- Class IIa
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- CH-MF-000042028
- Authorised representative
- Azienda Tecnica S.r.l. IT-AR-000039329
Other devices from Bio Brem SA
Properties & raw data
Show properties, registry sources and raw records
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
Sources (2)
- EUDAMED 5775a08f-a0cb-419c-b2dd-541834aa4409
- EUDAMED 07649989552020|7649989552SELF_THERAPYMB