← Back to catalogue
EKEEP K35 HYPERKEEP Iperestensore a 3 punti / Jewett TG 02
EUDAMEDClass I (EU MDR)
Ref 5K0143X01AB02
Identity
- Trade Name
- EKEEP K35 HYPERKEEP Iperestensore a 3 punti / Jewett TG 02 EUDAMED
- Device Name
- eKeep K35 HYPERKEEP Iperestensore a 3 punti / Jewett EUDAMED
- Model / Reference
- 5K0143X01AB02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08054382243083 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 02 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dual Sanitaly S.p.A. SB
- EUDAMED SRN
- IT-MF-000052906
Sources (1)
- EUDAMED e00031a9-bd7f-4965-afe7-2a8be1192b5d 61 fields · synced Jun 19, 2026