Awatar
by Awatar Medical Aid d.o.o. 4 variants
Ref 10Model AW216
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 | Number385889357AW216L3 03858893572831 | Date3 Dec 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- Withdrawn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
- Jewett Hyperextension Brace
- Model / Reference
- AW216, 10
- Primary DI / UDI-DI
- 03858893572831
- Basic UDI-DI
- 385889357AW216L3
- Direct Marketing DI
- 03858893572831
- EMDN Code
- Y060699 Orthoses, upper extremity - other
- Device Class
- Class I
- EU market of registration
- Croatia
Manufacturer details
- EUDAMED SRN
- HR-MF-000025777
Other devices from Awatar Medical Aid d.o.o.
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