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EKEEP K35 HYPERKEEP Iperestensore a 3 punti / Jewett TG 01
EUDAMEDClass I (EU MDR)
Ref 5K0143X01AB01
Identity
- Trade Name
- EKEEP K35 HYPERKEEP Iperestensore a 3 punti / Jewett TG 01 EUDAMED
- Device Name
- eKeep K35 HYPERKEEP Iperestensore a 3 punti / Jewett EUDAMED
- Model / Reference
- 5K0143X01AB01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08054382243076 EUDAMED
- Basic UDI-DI
- 8054382245K0143R5 EUDAMED
- EMDN Code
- Y060306 THORACOLUMBAR ORTHOSES 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 K35 HYPERKEEP Iperestensore a 3 punti / Jewett 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 | 8054382245K0143R5 | Class I | Active |
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Manufacturer
- Manufacturer
- Dual Sanitaly S.p.A. SB
- EUDAMED SRN
- IT-MF-000052906
Sources (1)
- EUDAMED e513454c-22f7-4dae-a85b-645790bdf3a5 61 fields · synced Jun 19, 2026