Magic-Soft-Anatom
by REBOTEC Rehabilitationsmittel GmbH 11 variants
Ref 1074010, 10730, 1075020, 1074020, 1074810, 1071010, 1078020, 1073010, 1074820, 1070020, 10748Model Unterarmgehstützen
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 | Number4046678_GHMTSC-0001-130GV | Date5 Mar 2024 | 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- Withdrawn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
- Model / Reference
- Unterarmgehstützen, 1074010, 10730, 1075020, 1074020, 1074810, 1071010, 1078020, 1073010, 1074820, 1070020, 10748
- Primary DI / UDI-DI
- 04046678007848, 04046678000238, 04046678007893, 04046678007855, 04046678007862, 04046678007800, 04046678007916, 04046678007824, 04046678007879, 04046678007794, 04046678000276
- Basic UDI-DI
- 4046678_GHMTSC-0001-130GV
- Direct Marketing DI
- 0404667800784804046678000238040466780078930404667800785504046678007862040466780078000404667800791604046678007824040466780078790404667800779404046678000276
- EMDN Code
- Y12030601 Elbow crutches
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000009447
Other devices from REBOTEC Rehabilitationsmittel 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