Sanisoft
by Promed GmbH kosmetische Erzeugnisse
Ref 521110
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 | Number04043641MEDSHOEAA | Date4 Nov 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- Withdrawn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
- Promed Verbandschuhe
- Model / Reference
- 521110
- Primary DI / UDI-DI
- 04043641500368, 04043641500344, 04043641500283, 04043641500351, 04043641500337, 04043641500399, 04043641500382, 04043641500375, 04043641500306, 04043641500313, 04043641500290, 04043641500320
- Basic UDI-DI
- 04043641MEDSHOEAA
- Direct Marketing DI
- 040436415003680404364150034404043641500283040436415003510404364150033704043641500399040436415003820404364150037504043641500306040436415003130404364150029004043641500320
- EMDN Code
- Y063303 Ready-made orthotic shoes
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000007206
Other devices from Promed GmbH kosmetische Erzeugnisse
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