Compression Socks
by Shijiazhuang aofeite imp&exp co., ltd 5 variants
Ref A226Model H016 H025 H026 H027 H028 H029 H030 H031 H032 H033 H034 H035 H036 H037 H038 H039 H040 H041 H042 H043 H044 H046 H047 H048 H050 H052 H053 H054 H055 H056 H057 H058 H059 H060 H061 H062 H064 H065 H069 H070 H071 etc
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 | Number69537519KNB01SX 06953751901192 | Date7 Nov 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- Withdrawn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
- Lower limb brace
- Model / Reference
- H016 H025 H026 H027 H028 H029 H030 H031 H032 H033 H034 H035 H036 H037 H038 H039 H040 H041 H042 H043 H044 H046 H047 H048 H050 H052 H053 H054 H055 H056 H057 H058 H059 H060 H061 H062 H064 H065 H069 H070 H071 etc, A226
- Primary DI / UDI-DI
- 06953751901192
- Basic UDI-DI
- 69537519KNB01SX
- EMDN Code
- Y061299 Lower extremity orthoses - other
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000011825
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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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