3D Printing Resin PORTUX 3D SG
by Productora Y Comercializadora Odontologica New Stetic S.a 3 variants
Ref 0028731 CEModel 3D Printing Resin PORTUX 3D SG 250 g
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 | Number7701126900634X7 07701126900634 | Date12 May 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- Withdrawn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
- Device Name
- 3D Printing Resin PORTUX 3D SG
- Model / Reference
- 3D Printing Resin PORTUX 3D SG 250 g, 0028731 CE
- Primary DI / UDI-DI
- 07701126900634
- Basic UDI-DI
- 7701126900634X7
- EMDN Code
- Q010699 Materials for the preparation of custom-made dental devices - other
- Device Class
- Class I
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- CO-MF-000036727
- Authorised representative
- Ranelagh Capital SLU ES-AR-000040175
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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