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EKEEP H1 HALLUX VALGUS Tutore diurno per alluce valgo TG 02
EUDAMEDClass I (EU MDR)
Ref 5K0802X00BA02
Identity
- Trade Name
- EKEEP H1 HALLUX VALGUS Tutore diurno per alluce valgo TG 02 EUDAMED
- Device Name
- ekeep H1 HALLUX VALGUS – Tutore diurno per alluce valgo EUDAMED
- Model / Reference
- 5K0802X00BA02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08054382242680 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
Category: Orthotic insole, prefabricated, non-antimicrobial
EKEEP H1 HALLUX VALGUS Tutore diurno per alluce valgo TG 02 by Dual Sanitaly S.p.A. SB — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Orthotic insole, prefabricated, non-antimicrobial.
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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 | 8054382245K0802RS | Class I | Active |
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Manufacturer
- Manufacturer
- Dual Sanitaly S.p.A. SB
- EUDAMED SRN
- IT-MF-000052906
Sources (1)
- EUDAMED 52152ce6-7874-4aa4-b043-f20dcf64eb54 61 fields · synced Jul 25, 2026