Identity
- Trade Name
- LAmbre EUDAMED
- Device Name
- LAmbre™ Left Atrial Appendage (LAA) Closure System EUDAMED
- Model / Reference
- Atrial closure EUDAMEDSL10F45-900 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938370124566 EUDAMED
- Basic UDI-DI
- B-06938370124566 EUDAMED
- EMDN Code
- P07040399 HEART AND CORONARY DEFECT OCCLUDERS - OTHER EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Italy 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
LAmbre by Lifetech Scientific (Shenzhen) Co., Ltd. — 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-06938370124566 | Class III | 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 3d5740ac-f173-43c9-993a-f42ca2e67d1e 61 fields · synced Jun 19, 2026