microneedling
by Ostar Beauty Sci-Tech Co Ltd 2 variants
Ref OB-MN80-011-N, OB-MN540-001-N, OB-MN20-005-N, OB-MN200-003-NModel OB-MN540,OB-MN20,OB-MN200,OB-MN80,OB-MN140
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 | Number697656787OBM23 | Date19 Dec 2025 | 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- Withdrawn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
- Model / Reference
- OB-MN540, OB-MN20, OB-MN200, OB-MN80, OB-MN140, OB-MN80-011-N, OB-MN540-001-N, OB-MN20-005-N, OB-MN200-003-N
- Primary DI / UDI-DI
- 06976567878014, 06976567875402, 06976567872012, 06976567872005
- Basic UDI-DI
- 697656787OBM23
- EMDN Code
- Z12069099 Various physiotherapy and rehabilitation instruments - other
- Device Class
- Class I
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000050259
- Authorised representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Other devices from Ostar Beauty Sci-Tech Co Ltd
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