Emovo Wear
Ref EW1-LM1, EW1-RS1, EW1-RM1, EW1-LL1, EW1-LS1
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number7649995625EW1QG | Date2 Apr 2026 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Emovo Wear
- Model / Reference
- EW1-LM1, EW1-RS1, EW1-RM1, EW1-LL1, EW1-LS1
- Primary DI / UDI-DI
- 07649995625084, 07649995625046, 07649995625053, 07649995625091, 07649995625077
- Basic UDI-DI
- 7649995625EW1QG
- EMDN Code
- Y060680 Upper limb orthoses - accessories
- Device Class
- Class I
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- CH-MF-000049487
- Authorised representative
- Donawa Lifescience Consulting Srl IT-AR-000007785
Other devices from Emovo Care
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