Identity
- Trade Name
- Kulani™ SC EUDAMED
- Device Name
- Kulani™ SC - Rx PTCA Balloon Dilatation Catheter EUDAMED
- Model / Reference
- KSL45012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18904224941431 EUDAMED
- Basic UDI-DI
- B-18904224941431 EUDAMED
- EMDN Code
- C010401020101 PTCA BALLOON DILATION CATHETERS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Spain 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
Kulani SC is a Class III, legacy medical device used for Obelis s.a. (Obelis) Rx PTCA Balloon Dilatation Catheter. This device has been certified by Meril Life Sciences Pvt. Ltd., and its primary use is to treat peripheral artery disease. With a specific indication for treating patients with severe or critical limb ischemia, Kulani SC has been designed to provide effective treatment while minimizing risks.
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-18904224941431 | Class III | Active |
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Manufacturer
- Manufacturer
- Meril Life Sciences Pvt. Ltd.
- EUDAMED SRN
- IN-MF-000008308
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 0a755bbb-31af-469b-86e6-a749cb3bb1cb 61 fields · synced Jun 24, 2026