Padded Elbow Support-Xl
by Hegeli̇ Ortopedi̇k Ürünler San.ltd.şti̇
Ref ARE2302-XL
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 | Number868085310379ARMZS | Date22 Nov 2024 | StatusActive |
Certificates
No notified-body 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- Withdrawn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
- Arm and Shoulder Braces
- Model / Reference
- ARE2302-XL
- Primary DI / UDI-DI
- 08680853103299
- Basic UDI-DI
- 868085310379ARMZS
- Direct Marketing DI
- 08680853103299
- EMDN Code
- Y090612 Arm and elbow protections
- Device Class
- Class I
- Market of Registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- TR-MF-000030874
Other devices from Hegeli̇ Ortopedi̇k Ürünler San.ltd.şti̇
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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