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Bunion Corrector
EUDAMEDClass I (EU MDR)
Ref 650001(XL/Right/Gray&Silver)Ref 650001(L/Left/Gray&Silver)Ref 650001(M/Left/Gray&Silver)Ref 650001(M/Right/Gray&Silver/PZB)Ref 650001(M/Left/Gray&Silver/PZB)Ref 650001(L/Right/Gray&Silver)Ref 650001(S/Left/Gray&Silver)Ref 650001(S/Right/Gray&Silver)Ref 650001(M/Right/Gray&Silver)
Identity
- Trade Name
- Bunion Corrector EUDAMED
- Device Name
- Insole (Hallux valgus metatarsophalangeal orthosis and toe separator) EUDAMED
- Model / Reference
- 650001(XL/Right/Gray&Silver) EUDAMED650001(L/Left/Gray&Silver) EUDAMED650001(M/Left/Gray&Silver) EUDAMED650001(M/Right/Gray&Silver/PZB) EUDAMED650001(M/Left/Gray&Silver/PZB) EUDAMED650001(L/Right/Gray&Silver) EUDAMED650001(S/Left/Gray&Silver) EUDAMED650001(S/Right/Gray&Silver) EUDAMED650001(M/Right/Gray&Silver) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719872868750 EUDAMED04719872866787 EUDAMED04719872866800 EUDAMED04719872868736 EUDAMED04719872868729 EUDAMED04719872866794 EUDAMED04719872866824 EUDAMED04719872866831 EUDAMED04719872866817 EUDAMED
- Basic UDI-DI
- 47198728665WU EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
Bunion Corrector by Zhangpu Ortholife Rehabilitation 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 | 47198728665WU | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zhangpu Ortholife Rehabilitation Co., Ltd.
- EUDAMED SRN
- CN-MF-000011447
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (9)
- EUDAMED aabf4ae8-06f8-4a84-b8c6-ba7b2988c9cd 61 fields · synced Oct 6, 2026
- EUDAMED e7494de5-0749-4736-85ab-476bdf1839bb 61 fields · synced May 16, 2026
- EUDAMED 4f592a82-5a90-4d99-a9ec-910248edaca0 61 fields · synced May 16, 2026
- EUDAMED adb77739-3775-4203-9cd5-b8c17de6121f 61 fields · synced May 17, 2026
- EUDAMED 8f7ba4ad-0e0d-49b1-851f-d063f3f649b8 61 fields · synced May 17, 2026
- EUDAMED 06c13695-92e4-4a55-979b-982a33f41287 61 fields · synced May 17, 2026
- EUDAMED 854220d8-9540-477f-96d0-5f0867b0ca57 61 fields · synced May 17, 2026
- EUDAMED 5fffc7c0-412a-47fa-8d57-39437a93369d 61 fields · synced May 18, 2026
- EUDAMED 92208dd5-f55d-4991-8e1e-10a638292c7f 61 fields · synced May 18, 2026