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EKEEP K1 POSTURE KEEPER WOMAN - Size 2
EUDAMEDClass I (EU MDR)
Ref 5K2254D00BA02
Identity
- Trade Name
- EKEEP K1 POSTURE KEEPER WOMAN - Size 2 EUDAMED
- Device Name
- K1 POSTURE KEEPER – Richiamo Dinamico Dorsale (eKeep) – versione Donna EUDAMED
- Model / Reference
- 5K2254D00BA02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08054382240143 EUDAMED
- Basic UDI-DI
- 8054382245K2254RV EUDAMED
- EMDN Code
- Y060399 SPINE ORTHOSES - OTHER 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 K1 POSTURE KEEPER WOMAN - Size 2 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 | 8054382245K2254RV | Class I | Active |
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Manufacturer
- Manufacturer
- Dual Sanitaly S.p.A. SB
- EUDAMED SRN
- IT-MF-000052906
Sources (1)
- EUDAMED a5438a1d-091a-4b16-ae7f-2f2b4484b95e 61 fields · synced Jun 19, 2026