Upper Limb Brace
by Anping Yikang Medical Instrument Co., Ltd EUDAMED
Active
Ref B101-1Model B101 B102 B103 B103-1 B103-2 B104 B104-1 B104-2 B105 B105-1 B106 B106-1 B106-2 B106-3 B107 B107-1 B107-2 B107-3 B108 B108-1 B109 B110 B111 B112 B201 B201-1 B201-2 B202 B202-1 B202-2 B203 B203-1 B203-2 B204 B204-1 B204-2 B205 B205-1 B205-2 B206 B206-1 etc
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697428637ULB01QS | Date13 Jan 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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
- Upper Limb Brace
- Model / Reference
- B101 B102 B103 B103-1 B103-2 B104 B104-1 B104-2 B105 B105-1 B106 B106-1 B106-2 B106-3 B107 B107-1 B107-2 B107-3 B108 B108-1 B109 B110 B111 B112 B201 B201-1 B201-2 B202 B202-1 B202-2 B203 B203-1 B203-2 B204 B204-1 B204-2 B205 B205-1 B205-2 B206 B206-1 etc, B101-1
- Primary DI / UDI-DI
- 06974286371908
- Basic UDI-DI
- 697428637ULB01QS
- EMDN Code
- Y060603 Fingers orthoses
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000045899
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Anping Yikang Medical Instrument Co., Ltd
See all devices from Anping Yikang Medical Instrument 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