Identity
- Trade Name
- EKEEP N1 NEUROSLING TG 1 EUDAMED
- Device Name
- EKEEP N1 NEUROSLING EUDAMED
- Model / Reference
- 5K1515X00BA01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08054382242710 EUDAMED
- Basic UDI-DI
- 8054382245K1515RT EUDAMED
- EMDN Code
- Y060621 SHOULDER 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 N1 Neurosling Tg 1 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 | 8054382245K1515RT | Class I | Active |
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Manufacturer
- Manufacturer
- Dual Sanitaly S.p.A. SB
- EUDAMED SRN
- IT-MF-000052906
Sources (1)
- EUDAMED bf4d5356-7101-44e8-8874-7066a8f6f1a8 61 fields · synced Oct 7, 2026