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Limb brace
EUDAMEDClass I (EU MDR)
Ref ES003Model ES001 ES002 ES003 ES004 ES005 ES006 ES007 HA001 HA002 HA003 HA004 KN001 KN002 KN003 KN004 KN005 KN006 KN007 KN08 KN009 KN010 KN011, etcRef NS017Ref SH002Ref WK007Ref WK025Ref KB007Ref WK015Ref KN009Ref WK009Ref WK026Ref KN024Ref ES011Ref SH005Ref KN025Ref ES009Ref HA003Ref KN005Ref NS014Ref WK018Ref ES004Ref SH004Ref NS007Ref NS006Ref WK014Ref KN030Ref NS010Ref KN004Ref KN022Ref WK006Ref KN006Ref KN014Ref HA002Ref TS001Ref ES012Ref KN026Ref SH003Ref KB001Ref WK023Ref HA001Ref KN008Ref WK024Ref KN010Ref ES005Ref KN020Ref WK004Ref NS009Ref NS004Ref KN017Ref NS013Ref ES001 ES002 ES003 ES004 ES005 ES006 ES007 HA001 HA002 HA003 HA004 KN001 KN002 KN03 etcRef WK028
Identity
- Device Name
- Limb brace EUDAMED
- Model / Reference
- ES001 ES002 ES003 ES004 ES005 ES006 ES007 HA001 HA002 HA003 HA004 KN001 KN002 KN003 KN004 KN005 KN006 KN007 KN08 KN009 KN010 KN011, etc EUDAMEDES003 EUDAMEDNS017 EUDAMEDSH002 EUDAMEDWK007 EUDAMEDWK025 EUDAMEDKB007 EUDAMEDWK015 EUDAMEDKN009 EUDAMEDWK009 EUDAMEDWK026 EUDAMEDKN024 EUDAMEDES011 EUDAMEDSH005 EUDAMEDKN025 EUDAMEDES009 EUDAMEDHA003 EUDAMEDKN005 EUDAMEDNS014 EUDAMEDWK018 EUDAMEDES004 EUDAMEDSH004 EUDAMEDNS007 EUDAMEDNS006 EUDAMEDWK014 EUDAMEDKN030 EUDAMEDNS010 EUDAMEDKN004 EUDAMEDKN022 EUDAMEDWK006 EUDAMEDKN006 EUDAMEDKN014 EUDAMEDHA002 EUDAMEDTS001 EUDAMEDES012 EUDAMEDKN026 EUDAMEDSH003 EUDAMEDKB001 EUDAMEDWK023 EUDAMEDHA001 EUDAMEDKN008 EUDAMEDWK024 EUDAMEDKN010 EUDAMEDES005 EUDAMEDKN020 EUDAMEDWK004 EUDAMEDNS009 EUDAMEDNS004 EUDAMEDKN017 EUDAMEDNS013 EUDAMEDES001 ES002 ES003 ES004 ES005 ES006 ES007 HA001 HA002 HA003 HA004 KN001 KN002 KN03 etc EUDAMEDWK028 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975816762128 EUDAMED06975816762760 EUDAMED06975816762784 EUDAMED06975816762890 EUDAMED06975816763071 EUDAMED06975816762593 EUDAMED06975816762975 EUDAMED06975816762340 EUDAMED06975816762913 EUDAMED06975816763088 EUDAMED06975816762494 EUDAMED06975816762203 EUDAMED06975816762814 EUDAMED06975816762500 EUDAMED06975816762180 EUDAMED06975816762241 EUDAMED06975816762302 EUDAMED06975816762739 EUDAMED06975816763002 EUDAMED06975816762135 EUDAMED06975816762807 EUDAMED06975816762661 EUDAMED06975816762654 EUDAMED06975816762968 EUDAMED06975816762555 EUDAMED06975816762692 EUDAMED06975816762296 EUDAMED06975816762470 EUDAMED06975816762883 EUDAMED06975816762319 EUDAMED06975816762395 EUDAMED06975816762234 EUDAMED06975816762821 EUDAMED06975816762210 EUDAMED06975816762517 EUDAMED06975816762791 EUDAMED06975816763118 EUDAMED06975816763057 EUDAMED06975816762227 EUDAMED06975816762333 EUDAMED06975816763064 EUDAMED06975816762357 EUDAMED06975816762142 EUDAMED06975816762456 EUDAMED06975816762869 EUDAMED06975816762685 EUDAMED06975816762630 EUDAMED06975816762425 EUDAMED06975816762722 EUDAMED06975816760063 EUDAMED06975816763101 EUDAMED
- Basic UDI-DI
- 697581676LB001KX 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
Yes
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
Limb brace by Xiamen Huakang Orthopedic 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 | 697581676LB001KX | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Xiamen Huakang Orthopedic Co., Ltd
- EUDAMED SRN
- CN-MF-000002290
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (51)
- EUDAMED 22156cea-7224-4c34-866b-cf1e3490cf8f 61 fields · synced Oct 6, 2026
- EUDAMED 82e5f00b-8d27-4ae6-840b-1f00f145518c 61 fields · synced May 11, 2026
- EUDAMED ca130b4c-1bb5-4ea5-96de-82a4ccd89427 61 fields · synced May 11, 2026
- EUDAMED e94721c8-d190-4a7a-8813-d073d5c84d4b 61 fields · synced May 11, 2026
- EUDAMED 140c7ff0-44e5-4f4e-b28b-6318ba1cebda 61 fields · synced May 11, 2026
- EUDAMED db5ec432-dcab-4324-926a-b4fe0e901a55 61 fields · synced May 16, 2026
- EUDAMED f4ed08f3-8d22-400e-ba7b-3ea1f48eb271 61 fields · synced May 16, 2026
- EUDAMED 88a7a645-26b2-41d2-becd-3d10ca2ad029 61 fields · synced May 16, 2026
- EUDAMED 006b6820-5379-45c4-8411-f40e5df9a288 61 fields · synced May 16, 2026
- EUDAMED 00edda09-1f4b-4c39-9fd0-e0f94086c38c 61 fields · synced May 16, 2026
- EUDAMED 38efb253-a662-40a7-b26e-065cedcaaf77 61 fields · synced May 16, 2026
- EUDAMED 24709fdb-4056-4577-ac38-a2a288802a2e 61 fields · synced May 16, 2026
- EUDAMED 21cb1981-531f-47f7-9d05-990c0f7e12f0 61 fields · synced May 16, 2026
- EUDAMED 21d0df94-d3fb-4e67-8477-bafac123aff3 61 fields · synced May 17, 2026
- EUDAMED 24f4bdb9-9de3-4ec6-9d09-ea34b16bdf19 61 fields · synced May 17, 2026
- EUDAMED 68d1a1a3-e656-447f-87d6-19ac05c3c33f 61 fields · synced May 17, 2026
- EUDAMED 481c26c2-d9a9-41cf-9e58-924a0d684ae6 61 fields · synced May 17, 2026
- EUDAMED 39e75c29-cff0-49c2-a948-3740bddac6f3 61 fields · synced May 17, 2026
- EUDAMED 23dd63b9-cd8f-4eba-b4b6-b32bbe9aee2f 61 fields · synced May 17, 2026
- EUDAMED 62ba522c-4f17-4170-9bbb-45fe54d519ad 61 fields · synced May 17, 2026
- EUDAMED e8c26eb5-2154-472c-bc92-df24d924f7db 61 fields · synced May 17, 2026
- EUDAMED c251eefc-775a-45c0-b056-b861459b162e 61 fields · synced May 17, 2026
- EUDAMED 922e6f5f-fbdf-42a9-9fa7-fad2e6cc2d64 61 fields · synced May 17, 2026
- EUDAMED 8a54ea02-2b58-47ab-9227-763227a62040 61 fields · synced May 17, 2026
- EUDAMED e569cdf6-52de-4671-849b-5e08dba28616 61 fields · synced May 17, 2026
- EUDAMED 67c7db6e-dd4c-4158-9728-eecc3e362855 61 fields · synced May 17, 2026
- EUDAMED 2ceb2e5f-7d01-445a-bc94-7cfd76ec8cb6 61 fields · synced May 18, 2026
- EUDAMED 124c7a14-b06f-4383-8bff-cdaa275609be 61 fields · synced May 18, 2026
- EUDAMED 9cd8b38e-0c79-4ef5-82ff-580a8ab5fa80 61 fields · synced May 18, 2026
- EUDAMED 9282747e-acca-4ea4-918b-8da57fd63fcb 61 fields · synced May 18, 2026
- EUDAMED 3ffd71e6-ea12-40f8-9bb4-71737e3fa583 61 fields · synced May 18, 2026
- EUDAMED 5d1e3c1f-fb1a-4a02-b0ca-0c0cb02cd440 61 fields · synced May 18, 2026
- EUDAMED 8eb47de3-6000-4025-9c01-51e728460541 61 fields · synced May 18, 2026
- EUDAMED a576bfb4-0cb1-4119-aa31-631147a84085 61 fields · synced May 18, 2026
- EUDAMED cb7eed7a-d665-4608-aacb-12fe1f218633 61 fields · synced May 18, 2026
- EUDAMED 2acc8de0-8c6c-4072-8687-b3b8a93e6ad7 61 fields · synced May 18, 2026
- EUDAMED 6fbda160-535f-4e29-ae98-faa3bc7c9b74 61 fields · synced May 18, 2026
- EUDAMED 48f0dc11-91d4-487e-bf0b-e09f498e86f5 61 fields · synced May 18, 2026
- EUDAMED a0fad00f-d757-4298-b08f-228cce3b136a 61 fields · synced May 18, 2026
- EUDAMED a27ea515-8450-47b9-9d3c-63df7a3cd309 61 fields · synced May 18, 2026
- EUDAMED 45bf9f1d-75cd-4887-9010-0fc391c1ac8c 61 fields · synced May 18, 2026
- EUDAMED fcb81981-ed5a-422c-8245-5bfb613ffb70 61 fields · synced May 18, 2026
- EUDAMED 952a29ad-50e7-47f4-8e46-87264bdc4335 61 fields · synced May 18, 2026
- EUDAMED 52343f0a-4cf9-4dc1-b34b-8ba6aa377dfb 61 fields · synced May 18, 2026
- EUDAMED 949efd29-8662-453b-b2b4-2da9dbec889e 61 fields · synced May 18, 2026
- EUDAMED 8ee1a27e-8eaa-42a9-9088-387d525fb45d 61 fields · synced May 18, 2026
- EUDAMED 7c01a374-025f-44ed-93ff-77ba87c4c250 61 fields · synced May 18, 2026
- EUDAMED ddbeb6df-aa82-4a44-ae10-8363d255f355 61 fields · synced May 18, 2026
- EUDAMED bf0d6ad8-8df6-43dc-93b1-ee5d8ef77a44 61 fields · synced May 18, 2026
- EUDAMED 28513922-8067-4887-af94-c8157b862d17 61 fields · synced May 18, 2026
- EUDAMED bdb9fba7-2220-4910-a20e-7541979b17ed 61 fields · synced May 19, 2026