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Lower Limb Brace
EUDAMEDClass I (EU MDR)
Ref N/AModel AN-301, AN-302, AN-303, AN-304, AN-305, AN-306, AN-307, AN-308, AN-309, AN-310, AN-311, AN-312, AN-313, AN-314, AN-315, AN-316, AN-317, AN-318, AN-319, AN-320, AN-321, AN-322, AN-323, AN-324, AN-325, AN-326, AN-327, AN-328 (or customized)
Identity
- Device Name
- Lower Limb Brace EUDAMED
- Model / Reference
- AN-301, AN-302, AN-303, AN-304, AN-305, AN-306, AN-307, AN-308, AN-309, AN-310, AN-311, AN-312, AN-313, AN-314, AN-315, AN-316, AN-317, AN-318, AN-319, AN-320, AN-321, AN-322, AN-323, AN-324, AN-325, AN-326, AN-327, AN-328 (or customized) EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975392693281 EUDAMED
- Basic UDI-DI
- 697539269ANLLBS3 EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) 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
Category: Orthotic insole, prefabricated, non-antimicrobial
Lower Limb Brace by Shenzhen Aonuo Medical Technology Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697539269ANLLBS3 | Class I | Active |
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Manufacturer
- Manufacturer
- Shenzhen Aonuo Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000038823
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 74898fe1-bd23-4d9d-b923-b30b282530d2 61 fields · synced Jul 25, 2026
- EUDAMED 74898fe1-bd23-4d9d-b923-b30b282530d2-1 61 fields · synced Jun 10, 2026