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Bunion Night Splint
EUDAMEDClass I (EU MDR)
Ref 650002(L/Left/White)Ref 650002(S/Left/White)Ref 650002(M/Right/White)Ref 650002(S/Right/White)Ref 650002(M/Left/White)Ref 650002(L/Right/White)
Identity
- Trade Name
- Bunion Night Splint EUDAMED
- Device Name
- Insole (Hallux valgus metatarsophalangeal orthosis and toe separator) EUDAMED
- Model / Reference
- 650002(L/Left/White) EUDAMED650002(S/Left/White) EUDAMED650002(M/Right/White) EUDAMED650002(S/Right/White) EUDAMED650002(M/Left/White) EUDAMED650002(L/Right/White) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719872866848 EUDAMED04719872866886 EUDAMED04719872866879 EUDAMED04719872866893 EUDAMED04719872866862 EUDAMED04719872866855 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 Night Splint 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 |
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Manufacturer
- Manufacturer
- Zhangpu Ortholife Rehabilitation Co., Ltd.
- EUDAMED SRN
- CN-MF-000011447
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (6)
- EUDAMED 190424f5-65cd-4cb7-ad76-c5d0b39ce4f2 61 fields · synced Oct 6, 2026
- EUDAMED b1c61bd7-c9aa-482b-90a2-014e8882c7ef 61 fields · synced May 17, 2026
- EUDAMED 51d2764d-3e20-4d8b-8876-a386a49f361b 61 fields · synced May 17, 2026
- EUDAMED a05d811b-f316-4a17-aeff-6280e3f5ccd1 61 fields · synced May 19, 2026
- EUDAMED 2e1ed7d2-633b-451b-a8da-11afb42db3a7 61 fields · synced May 19, 2026
- EUDAMED 805fb675-a667-4fab-93d7-0df86456d6ed 61 fields · synced May 19, 2026