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NICO Myriad SPECTRA
EUDAMEDFDA UDIClass I (EU MDR)
Ref NN-7048Model NICO Myriad SPECTRA
Identity
- Trade Name
- NICO Myriad SPECTRA EUDAMEDFDA UDI
- Generic Name
- Foot-switch, electrical FDA UDI
- Device Name
- Myriad SPECTRA Foot Pedal FDA UDI
- Model / Reference
- NICO Myriad SPECTRA EUDAMEDNN-7048 EUDAMEDFDA UDI
- Description
- Myriad SPECTRA Foot Pedal FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816744027483 EUDAMEDFDA UDI
- Basic UDI-DI
- 081674402MY6G6 EUDAMED
- FDA Product Code
- QFX FDA UDI
- EMDN Code
- Z12010902 ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE EUDAMED
- GMDN Term
- Foot-switch, electrical FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4950 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Foot-switch, electrical
NICO Myriad SPECTRA by NICO Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081674402MY6G6 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- NICO Corporation
- EUDAMED SRN
- US-MF-000000769
- Authorised Representative
- Atlantico Systems, Ltd. IE-AR-000000208
Sources (2)
- EUDAMED 870537ae-d0c0-46c9-b620-b6790b42f4e6 61 fields · synced Jun 8, 2026
- FDA UDI f900ce3d-64cd-4f15-b85e-a593f30fe632 34 fields · synced May 30, 2026