Lumbar Fixator
by Shenzhen Aonuo Medical Technology Co., Ltd. 4 variants
Ref AN-110, AN-118, AN-115, AN-112, AN-114Model AN-110/AN-111/AN-112/AN-113/AN-114/AN-115/AN-116/AN-117/AN-118 customized
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 | Number697539269ANLFSG | Date24 Nov 2023 | 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- Withdrawn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
- Lumbar Fixator
- Model / Reference
- AN-110/AN-111/AN-112/AN-113/AN-114/AN-115/AN-116/AN-117/AN-118 customized, AN-110, AN-118, AN-115, AN-112, AN-114
- Primary DI / UDI-DI
- 06975392691102, 06975392691188, 06975392691157, 06975392691126, 06975392691140
- Basic UDI-DI
- 697539269ANLFSG
- EMDN Code
- Y060306 Thoracolumbar orthoses
- Device Class
- Class I
- EU market of registration
- AustriaFrance
Manufacturer details
- EUDAMED SRN
- CN-MF-000038823
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Shenzhen Aonuo Medical Technology Co., Ltd.
See all devices from Shenzhen Aonuo Medical Technology Co., Ltd. →
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