EMS860
by EMS Physio ltd United Kingdom EUDAMED
Ref EMS860Model Primo Ultrasound & Electrical Simulation, Primo combination therapy
EMDN Z120601
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | Number506030097EMS8600Y7 | Date27 May 2026 | StatusActive |
| European Union | CE/MDR | Number506030097EMS8600Y7 | Date27 May 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDD, CE/MDR Active
Specification
- Trade Name
- Primo combination therapy
- Model / Reference
- Primo Ultrasound & Electrical Simulation, EMS860, Primo combination therapy
- Primary DI / UDI-DI
- 05060300970019
- Basic UDI-DI
- 506030097EMS8600Y7, B-05060300970019
- EMDN Code
- Z120601 Electrotherapy equipment (included tens)
- Device Class
- Class IIb
- Market of Registration
- Malta
Manufacturer details
- EUDAMED SRN
- GB-MF-000029343
- Authorised representative
- Advena Limited MT-AR-000000234
Other devices from Ems Physio Ltd.
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 4d955e11-3862-411d-b8af-cfbe898d6099
- EUDAMED fff015b0-3722-4d80-b1d8-4ebb217cd662