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Najuta Thoracic Stent Graft System
EUDAMEDClass III (EU MDR)
Ref AR8L-S42CL3-3U95
Identity
- Trade Name
- Najuta Thoracic Stent Graft System EUDAMED
- Device Name
- Najuta Thoracic Stent Graft System EUDAMED
- Model / Reference
- AR8L-S42CL3-3U95 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987488107604 EUDAMED
- Basic UDI-DI
- B-04987488107604 EUDAMED
- EMDN Code
- P07040199 VASCULAR ENDOPROSTHESES - OTHER EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Najuta Thoracic Stent Graft System by Sb-Kawasumi Laboratories, Inc. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04987488107604 | Class III | Active |
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Manufacturer
- Manufacturer
- Sb-Kawasumi Laboratories, Inc.
- EUDAMED SRN
- JP-MF-000011253
- Authorised Representative
- MPS Medical Product Service GmbH DE-AR-000005009
Sources (1)
- EUDAMED 1e471c4f-1fbb-42a7-834c-4308503ed432 61 fields · synced Jul 8, 2026