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EluNIR-PERL™ Ridaforolimus Eluting Coronary Stent System
EUDAMEDClass III (EU MDR)
Ref ELM350R44IN
by Medinol Ltd
Identity
- Trade Name
- EluNIR-PERL™ Ridaforolimus Eluting Coronary Stent System EUDAMED
- Device Name
- EluNIR-PERL Ridaforolimus Eluting Coronary Stent System EUDAMED
- Model / Reference
- ELM350R44IN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290107017190 EUDAMED
- Basic UDI-DI
- 729010701ELMPERL000IN6Q EUDAMED
- EMDN Code
- P070402010301 CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
Yes
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
Yes
EUDAMED
EluNIR-PERL™ Ridaforolimus Eluting Coronary Stent System by Medinol Ltd. — Class III — 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 | 729010701ELMPERL000IN6Q | Class III | Active |
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Manufacturer
- Manufacturer
- Medinol Ltd
- EUDAMED SRN
- IL-MF-000013929
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (1)
- EUDAMED 5b1af798-d1cc-4ac9-a39d-22ae3ad63590 61 fields · synced Jun 18, 2026