Opaska elastyczna stawu łokciowego (M)
Ref OG-EEL001
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 | Number5903981322ortezyRM 05903981322305 | Date23 Dec 2021 | 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- Withdrawn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
- Ortezy
- Model / Reference
- OG-EEL001
- Primary DI / UDI-DI
- 05903981322305
- Basic UDI-DI
- 5903981322ortezyRM
- EMDN Code
- Y060615 Elbow orthoses
- Device Class
- Class I
- EU market of registration
- Poland
Manufacturer details
- EUDAMED SRN
- PL-MF-000002247
From the manufacturer
Manufacturer's product page: Opaska elastyczna OG-EWR001
Other devices from Orthoguard Maciej Tomczuk
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