Identity
- Trade Name
- Fustar EUDAMED
- Device Name
- Fustar™ Steerable Introducer EUDAMED
- Model / Reference
- SVA12F-900 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938370116882 EUDAMED
- Basic UDI-DI
- B-06938370116882 EUDAMED
- EMDN Code
- P0780 VASCULAR AND CARDIAC PROSTHESES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
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
Fustar by Lifetech Scientific (Shenzhen) Co., Ltd. — Class IIa — 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-06938370116882 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Lifetech Scientific (Shenzhen) Co., Ltd.
- EUDAMED SRN
- CN-MF-000001561
- Authorised Representative
- LifeTech Scientific (Europe) B.V. NL-AR-000000804
Sources (1)
- EUDAMED 40189810-6df0-477d-90c0-176f8c4038d1 61 fields · synced May 23, 2026