Softtouch
by Anita Dr. Helbig GmbH 2 variants
Ref 1052X2
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 | Number4009706Y06301801XR | Date8 Jun 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- Withdrawn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
- Breast prostheses, external
- Model / Reference
- 1052X2
- Primary DI / UDI-DI
- 04009706569428, 04009706569480, 04009706569442, 04009706569503, 04009706569398, 04009706569459, 04009706569473, 04009706569435, 04009706569411
- Basic UDI-DI
- 4009706Y06301801XR
- Direct Marketing DI
- 040097065694280400970656948004009706569442040097065695030400970656939804009706569459040097065694730400970656943504009706569411
- EMDN Code
- Y063018 External breast prostheses
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- DE-MF-000012631
Other devices from Anita Dr. Helbig GmbH
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