ACHILLO-HiT
Ref 07804
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 | Number04029925Y06120601V7 | Date16 Oct 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- Withdrawn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
- Swede-O-Universal
- Model / Reference
- 07804
- Primary DI / UDI-DI
- 04029925011522, 04029925140925, 04029925255421, 04029925240786, 04029925255407, 04029925255513, 04029925140970, 04029925255438, 04029925255490, 04029925240762, 04029925255568, 04029925140987, 04029925255506, 04029925011485, 04029925255452, 04029925140949, 04029925011560, 04029925140994, 04029925255537, 04029925011553, 04029925240779, 04029925255384, 04029925255483, 04029925255520, 04029925255414, 04029925255445, 04029925011508, 04029925255377, 04029925255544, 04029925011478, 04029925141014, 04029925141007, 04029925011539, 04029925255391, 04029925255551, 04029925140956, 04029925140932, 04029925255360, 04029925255582, 04029925255575, 04029925240793, 04029925255599, 04029925011546, 04029925140963, 04029925255476, 04029925011515, 04029925255469, 04029925011492
- Basic UDI-DI
- 04029925Y06120601V7
- EMDN Code
- Y06120601 Passive ankle-foot orthoses
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000006346
Other devices from SPORLASTIC GMBH & Co.KG
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