Identity
- Trade Name
- SeQure EUDAMEDSeQureTM Snare System FDA UDI
- Generic Name
- Intravascular extraction catheter-snare FDA UDI
- Device Name
- SeQure™ Snare System EUDAMEDThe SeQureTM Snare System consists of a snare, a catheter, a loader and a torquer. The snare is constructed of a nitinol shaft and a loop with the plane of the loop perpendicular to the nitinol shaft. The nitinol loop is covered with a tungsten coil which is coated by laminated titanium and its nitride to enhance radiopaque. The pre-formed snare loop can be introduced through catheter without risk of permanent deformiation because of super-elasticity of nitinol material. The catheter consists of luer connector and PE tubing with a radiopaque markband at its distal tip to enhance the visibility during the operation. The snare is pre-assembled with the loader and the torque, and then packaged together with corresponding catheter. FDA UDI
- Model / Reference
- LT-SP-25 EUDAMEDFDA UDI
- Description
- The SeQureTM Snare System consists of a snare, a catheter, a loader and a torquer. The snare is constructed of a nitinol shaft and a loop with the plane of the loop perpendicular to the nitinol shaft. The nitinol loop is covered with a tungsten coil which is coated by laminated titanium and its nitride to enhance radiopaque. The pre-formed snare loop can be introduced through catheter without risk of permanent deformiation because of super-elasticity of nitinol material. The catheter consists of luer connector and PE tubing with a radiopaque markband at its distal tip to enhance the visibility during the operation. The snare is pre-assembled with the loader and the torque, and then packaged together with corresponding catheter. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06938370118091 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06938370118091 EUDAMED
- 510(k) Number
- K102484 FDA UDI
- FDA Product Code
- MMX FDA UDI
- EMDN Code
- C019005 RETRIEVING SYSTEMS FOR VASCULAR FOREIGN BODIES EUDAMED
- GMDN Term
- Intravascular extraction catheter-snare FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.5150 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
SeQure by Lifetech Scientific (Shenzhen) Co., Ltd. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06938370118091 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 (2)
- EUDAMED c5ab0e7f-a010-4c10-8249-4459a3b2609b 61 fields · synced Jul 29, 2026
- FDA UDI cef90f86-42a6-41e6-84d0-094cd59dc1cb 34 fields · synced May 29, 2026