Lower Limb/Upper Limb Prosthetics Parts
by Hebei Stand Up Medical Technology Co., Ltd. 85 variants
Ref L0332-A, L0903-T, J0101-A, L15-T, KZ01-T, L1775-S, L36420-CS, L1645-S, Q1710026, UL01, L0375-A, L47, KR58, UL12, L1860-T, Q1903, L1745-T, L25-S, L0904-S, J020405-A, L46, L1832-S, Q1040, Q1080, L1845-S, L1732-T, KR98, UL02, L2245-T, Q36, UL13, L0105-T, UL15, L1675-T, UL16, KR78, L0901-T, L1760-T, L35420-AA, L23-S, Q3302, L15-S, J0210-A, Q1710050, L080370-T, L24-S, L19-S, J020402-A, L13-S, J020302-S, L0545-AModel 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
Active
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 | Number697876080LIMB001ZF | Date11 Jun 2025 | 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- Withdrawn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
- 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, L0903-T, L15-T, KZ01-T, L1775-S, L36420-CS, L1645-S, Q1710026, UL01, L0375-A, L47, KR58, UL12, L1860-T, Q1903, L1745-T, L25-S, L0904-S, J020405-A, L46, L1832-S, Q1040, Q1080, L1845-S, L1732-T, KR98, UL02, L2245-T, Q36, UL13, UL15, L1675-T, UL16, KR78, L0901-T, L1760-T, L35420-AA, L23-S, Q3302, L15-S, J0210-A, Q1710050, L080370-T, L24-S, L19-S, J020402-A, L13-S, J020302-S, L0545-A
- Primary DI / UDI-DI
- 06978760800229, 06978760800564, 06978760800106, 06978760800823, 06978760801837, 06978760800984, 06978760801462, 06978760800885, 06978760802926, 06978760803459, 06978760800250, 06978760801875, 06978760801776, 06978760803565, 06978760801011, 06978760803015, 06978760800922, 06978760801257, 06978760800571, 06978760802025, 06978760801868, 06978760801042, 06978760802810, 06978760802827, 06978760801059, 06978760800915, 06978760801813, 06978760803466, 06978760801165, 06978760803350, 06978760803572, 06978760800168, 06978760803596, 06978760800861, 06978760803602, 06978760801790, 06978760800519, 06978760800939, 06978760801448, 06978760801219, 06978760803312, 06978760800816, 06978760802094, 06978760802933, 06978760800441, 06978760801233, 06978760801103, 06978760801998, 06978760800786, 06978760801974, 06978760800304
- Basic UDI-DI
- 697876080LIMB001ZF
- EMDN Code
- Y0699 External prostheses and orthoses - other
- Device Class
- Class I
- EU 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