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Upper Limb Brace
EUDAMEDClass I (EU MDR)
Ref BZ111Model BZ111 BZ112 BZ113 BZ114 BZ115 BZ116 BZ117 BZ118 BZ119 BZ120 BZ121 BZ122 BZ123 BZ124 BZ125 BZ126 BZ127 BZ128 BZ129 BZ130 S110 S111 S112 S113 S114 S115 S116 S117 S118 S119 S120 S121 S122 S123 S124 S125 S126 S127 S128 S129 S130 UB001 UB002 etc
Identity
- Device Name
- Upper Limb Brace EUDAMED
- Model / Reference
- BZ111 BZ112 BZ113 BZ114 BZ115 BZ116 BZ117 BZ118 BZ119 BZ120 BZ121 BZ122 BZ123 BZ124 BZ125 BZ126 BZ127 BZ128 BZ129 BZ130 S110 S111 S112 S113 S114 S115 S116 S117 S118 S119 S120 S121 S122 S123 S124 S125 S126 S127 S128 S129 S130 UB001 UB002 etc EUDAMEDBZ111 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974141900007 EUDAMED
- Basic UDI-DI
- 697414190ULB001GP EUDAMED
- EMDN Code
- Y060680 UPPER LIMB ORTHOSES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Upper Limb Brace by Hengshui Jingkang Medical Device Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697414190ULB001GP | Class I | Active |
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Manufacturer
- Manufacturer
- Hengshui Jingkang Medical Device Co., Ltd
- EUDAMED SRN
- CN-MF-000041859
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED d38b2dc0-01e0-4562-8fb3-b506728f7ff0 61 fields · synced Jun 19, 2026