Style Santa Marta Top
by Anita Dr. Helbig GmbH EUDAMED
Active
Ref M3-6524-1
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number4009706Y06309902ZQ | Date17 Jun 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Prosthetic swimwear
- Model / Reference
- M3-6524-1
- Primary DI / UDI-DI
- 04058509538438, 04058509538391, 04058509538353, 04058509538384, 04058509538452, 04058509538476, 04058509538469, 04058509538346, 04058509538490, 04058509538414, 04058509538322
- Basic UDI-DI
- 4009706Y06309902ZQ
- Direct Marketing DI
- 0405850953843804058509538391040585095383530405850953838404058509538452040585095384760405850953846904058509538346040585095384900405850953841404058509538322
- EMDN Code
- Y063099 Non-extremity prostheses - other
- Device Class
- Class I
- 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