Lower limb brace
by Shijiazhuang aofeite imp&exp co., ltd 14 variants
Ref AFT0100, HX020, Ankle brace BP-H081-01, A225, H014, OrtoCare bokaszorító szilikon betéttel L H102 GYVFBSZL, Bütyök és lábujj védő (L) ZSR6 GYVFBLVL, Bütyök és lábujj védő (S) ZSR6 GYVFBLVS, Bütyök és lábujj védő (M) ZSR6 GYVFBLVM, OrtoCare bokaszorító szilikon betéttel XL H102 GYVFBSZXL, ZSN6 GYVFCBSModel Ankle brace BP-H081-01 BP-H081-02 BP-H081-03 BP-H081-04 Ankle brace HH235-1 Ankle brace AFT0104 knee brace BP-H044-01 BP-H044-02 BP-H044-03 BP-H044-04 BP-H044-05 Knee brace A084 etc, H016,H025,H026,H027,H028,H029,H030,H031,H032,H033,H034,H035,H036,H037,H038,H039,H040,H041,H042,H043,H044,H045,H046,H047,H048, H050,H052,H053,H054,H055,H056,H057,H058,H059,H060,H061,H062,H064,H065,H069, 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
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 | Number697852731LLB01N5 | Date16 Apr 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- Withdrawn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
- Trade Name
- Knee braceCompression SocksShoulder brace
- Device Name
- Lower limb brace
- Model / Reference
- Ankle brace BP-H081-01 BP-H081-02 BP-H081-03 BP-H081-04 Ankle brace HH235-1 Ankle brace AFT0104 knee brace BP-H044-01 BP-H044-02 BP-H044-03 BP-H044-04 BP-H044-05 Knee brace A084 etc, AFT0100, H016, H025, H026, H027, H028, H029, H030, H031, H032, H033, H034, H035, H036, H037, H038, H039, H040, H041, H042, H043, H044, H045, H046, H047, H048, H050, H052, H053, H054, H055, H056, H057, H058, H059, H060, H061, H062, H064, H065, H069, HX020, Ankle brace BP-H081-01, 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, A225, H014, OrtoCare bokaszorító szilikon betéttel L H102 GYVFBSZL, Bütyök és lábujj védő (L) ZSR6 GYVFBLVL, Bütyök és lábujj védő (S) ZSR6 GYVFBLVS, Bütyök és lábujj védő (M) ZSR6 GYVFBLVM, OrtoCare bokaszorító szilikon betéttel XL H102 GYVFBSZXL, ZSN6 GYVFCBS
- Primary DI / UDI-DI
- 06978527310398, 06953751901208, 06978527310275, 06953751901185, 06953760901053, 06953751901451, 06953751901468, 06953751901253, 06953751901567, 06953751901147, 06953751901246
- Basic UDI-DI
- 697852731LLB01N5, 697852731ULBXF, 69537519KNB01SX, 69748LLB001LY
- EMDN Code
- Y061209, Y061216, Y061280, Y061299, Y060621, Y061203
- Device Class
- Class I
- EU market of registration
- GermanyAustria
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