Standard Thumb Support - Universal
by Hegeli̇ Ortopedi̇k Ürünler San.ltd.şti̇
Ref ARH5015-STD
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 | Number868085311ARMALLL6 08680853107112 | Date28 Nov 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- Withdrawn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
- Device Name
- Armall
- Model / Reference
- ARH5015-STD
- Primary DI / UDI-DI
- 08680853107112
- Basic UDI-DI
- 868085311ARMALLL6
- Direct Marketing DI
- 08680853107112
- EMDN Code
- Y060603 Fingers orthoses
- Device Class
- Class I
- EU 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