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Lithonic
EUDAMEDClass IIb (EU MDR)
Ref CILG-0001Ref CILA-0001Ref CILA-0005Ref CILA-0003Ref CILA-0002
Identity
- Trade Name
- Lithonic EUDAMED
- Device Name
- Lithonic Coronary Intravascular Lithotripsy (IVL) Generator EUDAMEDLithonic Connecting Cable F EUDAMED
- Model / Reference
- CILG-0001 EUDAMEDCILA-0001 EUDAMEDCILA-0005 EUDAMEDCILA-0003 EUDAMEDCILA-0002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08885021690186 EUDAMED08885021690216 EUDAMED08885021690193 EUDAMED08885021690230 EUDAMED08885021690223 EUDAMED
- Basic UDI-DI
- 888502169CILGMQ EUDAMED888502169CILAMC EUDAMED
- EMDN Code
- Z12059099 VARIOUS INSTRUMENTS FOR CARDIOLOGY AND CARDIAC SURGERY -OTHER EUDAMEDZ12059080 VARIOUS INSTRUMENTS FOR CARDIOLOGY AND CARDIAC SURGERY - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass I EUDAMED
- Market of Registration
- Netherlands 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
Lithonic by Biosensors Interventional Technologies Pte Ltd — Class IIb — 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 | 888502169CILGMQ | Class IIb | Active |
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Manufacturer
- Manufacturer
- Biosensors Interventional Technologies Pte Ltd
- EUDAMED SRN
- SG-MF-000015765
- Authorised Representative
- NVT GmbH DE-AR-000006441
Sources (5)
- EUDAMED fc1ba0ef-53c8-4384-8dfd-653db493a0c0 61 fields · synced Oct 6, 2026
- EUDAMED ad87aa23-d9dc-44ca-bb63-f0138435df54 61 fields · synced Jul 16, 2026
- EUDAMED 78e67b53-4951-41ee-83ab-db4763d28350 61 fields · synced Jul 19, 2026
- EUDAMED 605b4f29-5f1f-4ce6-8d24-dece63676f52 61 fields · synced Jul 20, 2026
- EUDAMED 8969a9ff-8879-42eb-b3d3-338b1d228c01 61 fields · synced Jul 20, 2026