Identity
- Trade Name
- IRILLIC.NM EUDAMED
- Device Name
- FLUORESCENCE IMAGING SYSTEM EUDAMED
- Model / Reference
- OF81 EUDAMEDOAK001-D-0001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08908015516047 EUDAMED
- Basic UDI-DI
- 8908015516IRFISAH EUDAMED
- EMDN Code
- Z11039099 VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS – OTHER EUDAMED
Classification
- Device Class
- Class IIa 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
Category: Electromagnetic surgical navigation device tracking system
Irillic.nm by Irillic Private Limited — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Electromagnetic surgical navigation device tracking system.
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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 | 8908015516IRFISAH | Class IIa | Active |
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Manufacturer
- Manufacturer
- Irillic Private Limited
- EUDAMED SRN
- IN-MF-000028160
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 47e8685c-63ba-4405-aeae-d8ffe715fd36 61 fields · synced Jul 22, 2026