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NICO Myriad NOVUS
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref NN-7014Model NICO Myriad510(k) K191599
Identity
- Trade Name
- NICO Myriad NOVUS EUDAMED
- Model / Reference
- NICO Myriad EUDAMEDNN-7014 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00816744027148 EUDAMED
- Basic UDI-DI
- 081674402MY3FY EUDAMED
- EMDN Code
- Z12010902 ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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: Foot-switch, electrical
NICO Myriad NOVUS by NICO Corporation — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K191599 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 081674402MY3FY | Class IIb | Active |
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Manufacturer
- Manufacturer
- NICO Corporation
- EUDAMED SRN
- US-MF-000000769
- Authorised Representative
- Atlantico Systems, Ltd. IE-AR-000000208
Sources (2)
- EUDAMED 726159b6-84dd-47aa-9e29-6a77e074c11d 85 fields · synced Jun 18, 2026
- FDA 510(k) K191599 1 fields · synced May 18, 2026