Male Four-prong with Bore-SA（LA101-BS）
Ref LA101-BSModel LA101-BS;LA101-BT
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 | Number697263500PMA06GH 06972635000165 | Date20 Mar 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- Withdrawn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
- Prosthesis metal adapter
- Model / Reference
- LA101-BS, LA101-BT
- Primary DI / UDI-DI
- 06972635000165
- Basic UDI-DI
- 697263500PMA06GH
- EMDN Code
- Y061280 Lower limb orthoses - accessories
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000039565
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Xiangtan Alps P&O 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