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Upper Limb Brace(Shoulder Orthosis)
EUDAMEDFDA UDIClass I (EU MDR)
Ref Shoulder Orthosis-XSModel XXS,XS,S,M,L,XL,XXL,XXXL
Identity
- Trade Name
- HuaKang FDA UDI
- Generic Name
- Ankle/foot orthosis FDA UDI
- Device Name
- Upper Limb Brace(Shoulder Orthosis) EUDAMED
- Model / Reference
- XXS,XS,S,M,L,XL,XXL,XXXL EUDAMEDShoulder Orthosis-XS EUDAMEDS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975813110014 EUDAMEDFDA UDI
- Basic UDI-DI
- 697581311SO01MD EUDAMED
- FDA Product Code
- ITW FDA UDI
- EMDN Code
- Y060621 SHOULDER ORTHOSES EUDAMED
- GMDN Term
- Ankle/foot orthosis FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3475 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Upper Limb Brace(Shoulder Orthosis) by Anping Huakang Medical Products Factory — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697581311SO01MD | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- AnPing HuaKang Medical Products Factory
- EUDAMED SRN
- CN-MF-000036122
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 37068ee9-5996-413b-a2e8-7c39e977db68 61 fields · synced Jun 18, 2026
- FDA UDI bd13ff29-2863-4052-8726-a965a88ab306 32 fields · synced May 30, 2026