Lower Limb/Upper Limb Prosthetics Parts
by Hebei Stand Up Medical Technology Co., Ltd. EUDAMED
Active
Ref L0802-TModel J0101-T,J0101-S,J0102-T,J0102-S,J0103-T,J0103-S,J0104-T,J0104-S,J0105-T,J0105-S,J0101-A,L0101-A,L0102-A,L0103-A,L0104-A,L0105-A,L0105-T,L0106-A,L0107-A,L010801-A,L010802-A,L02-A,L0332-A,L0345-A,L0360-A, etc
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697876080LIMB001ZF | Date11 Jun 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Lower Limb/Upper Limb Prosthetics Parts
- Model / Reference
- J0101-T, J0101-S, J0102-T, J0102-S, J0103-T, J0103-S, J0104-T, J0104-S, J0105-T, J0105-S, J0101-A, L0101-A, L0102-A, L0103-A, L0104-A, L0105-A, L0105-T, L0106-A, L0107-A, L010801-A, L010802-A, L02-A, L0332-A, L0345-A, L0360-A, etc, L0802-T
- Primary DI / UDI-DI
- 06978760800397
- Basic UDI-DI
- 697876080LIMB001ZF
- EMDN Code
- Y0699 External prostheses and orthoses - other
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000048178
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Hebei Stand Up Medical Technology Co., Ltd.
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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