Electrodo ReCure
by Aneuvo
Ref PAD-003Model EXA-001
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number0850053287EXSYYU 00850053287091 | Date13 Jun 2025 | 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- Withdrawn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
- ExaStim Stimulation System
- Model / reference
- EXA-001, PAD-003
- Primary DI / UDI-DI
- 00850053287091
- Basic UDI-DI
- 0850053287EXSYYU
- EMDN code
- Z120601 Electrotherapy equipment (included tens)
- Device class
- Class IIb
- System or procedure pack
- System which is a device in itself
- EU registration type
- Standard device
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- US-MF-000041520
- Authorised representative
- Obelis s.a. BE-AR-000000106
Other devices from Aneuvo
Properties
Other properties (14)
- Supplied sterile: No
- Sterilise before use: No
- Implantable: No
- Reusable: No
- Contains latex: No
- Reprocessed single-use device: No
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
- Incorporates a substance derived from human blood or plasma: No
- Contains human tissues or cells: No
- Contains animal tissues or cells: No
- Contains endocrine-disrupting substances: No
- Administering medicine: No
- Measuring function: No
- Incorporates a medicinal substance: No