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EKEEP H1 HALLUX VALGUS Tutore diurno per alluce valgo TG 01
EUDAMEDClass I (EU MDR)
Ref 5K0802X00BA01
Identity
- Trade Name
- EKEEP H1 HALLUX VALGUS Tutore diurno per alluce valgo TG 01 EUDAMED
- Device Name
- ekeep H1 HALLUX VALGUS – Tutore diurno per alluce valgo EUDAMED
- Model / Reference
- 5K0802X00BA01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08054382242673 EUDAMED
- Basic UDI-DI
- 8054382245K0802RS EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
EKEEP H1 HALLUX VALGUS Tutore diurno per alluce valgo TG 01 by Dual Sanitaly S.p.A. SB — 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 | 8054382245K0802RS | Class I | Active |
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Manufacturer
- Manufacturer
- Dual Sanitaly S.p.A. SB
- EUDAMED SRN
- IT-MF-000052906
Sources (1)
- EUDAMED f203ea5a-6410-4749-b800-af1c58490695 61 fields · synced Oct 7, 2026