Orteza na ramię i bark typu Dessault RS1 (Ortopedio by Synoptis)
by Private Enterprise Remed 4 variants
Ref 04820183234520Model R9108
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 | Number018323R9108TW 04820183234520 | Date24 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- Withdrawn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
- Supporting bandage for the shoulder joint and arm (Desault Bandage)
- Model / Reference
- R9108, 04820183234520
- Primary DI / UDI-DI
- 04820183234520
- Basic UDI-DI
- 018323R9108TW
- EMDN Code
- Y060624 Shoulder-elbow orthoses
- Device Class
- Class I
- EU market of registration
- Poland
Manufacturer details
- EUDAMED SRN
- UA-MF-000056451
- Authorised representative
- GSI-CERT German Scientific Institute for Quality, Testing and Certification GmbH DE-AR-000056188
Other devices from Private Enterprise Remed
Properties
Other properties (12)
- Sterile: No
- Implantable: No
- Reusable: 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