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NICO Myriad
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref NN-7011Model NICO MyriadRef NN-7001Ref NN-9003Ref NN-9009
Identity
- Trade Name
- NICO Myriad EUDAMEDFDA UDI
- Generic Name
- Surgical suction system collection container, single-use FDA UDIElectromechanical device/system transport trolley FDA UDI
- Device Name
- Filter Element Replacement - Scoop FDA UDIConsole Cart FDA UDIFilter Element Replacement - Clamshell FDA UDI
- Model / Reference
- NICO Myriad EUDAMEDNN-7011 EUDAMEDNN-7001 EUDAMEDFDA UDINN-9009 EUDAMEDFDA UDINN-9003 EUDAMEDFDA UDI
- Description
- Filter Element Replacement - Scoop FDA UDIConsole Cart FDA UDIFilter Element Replacement - Clamshell FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816744027117 EUDAMED00816744027018 EUDAMEDFDA UDI00816744029098 EUDAMEDFDA UDI00816744029036 EUDAMEDFDA UDI
- Basic UDI-DI
- 081674402MY5G4 EUDAMED081674402MY4G2 EUDAMED
- FDA Product Code
- FMH FDA UDIGEI FDA UDI
- EMDN Code
- Z12010980 ELECTROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMEDA090199 ORGAN COLLECTION CONTAINERS - OTHER EUDAMED
- GMDN Term
- Surgical suction system collection container, single-use FDA UDIElectromechanical device/system transport trolley FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDIClass II FDA UDI
- Regulation Number
- 864.3250 FDA UDI878.4400 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDIEUDAMEDFDA UDI
Single Use
Yes
FDA UDIFDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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
Yes
FDA UDIFDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDIFDA UDI
Manufacturing Date
No
FDA UDI
NICO Myriad by NICO Corporation — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
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 | K182340 | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K161307 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 081674402MY5G4 | Class I | Active |
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Manufacturer
- Manufacturer
- NICO Corporation
- EUDAMED SRN
- US-MF-000000769
- Authorised Representative
- Atlantico Systems, Ltd. IE-AR-000000208
Sources (8)
- EUDAMED 7f32f063-a959-4746-9922-0881faa976c9 61 fields · synced Jul 15, 2026
- EUDAMED 0b396d98-0edf-4add-8637-8f9bcbd10e50 61 fields · synced May 18, 2026
- FDA UDI 5da18738-0daa-4167-8a91-25e653c7758c 34 fields · synced May 30, 2026
- FDA UDI 32336e8e-f050-4ade-a4be-525dccc9f95d 34 fields · synced May 30, 2026
- FDA UDI b498a27b-abb9-4059-96df-5c7775c270ee 34 fields · synced May 30, 2026
- EUDAMED b8829d46-16c9-4ee6-ad6a-13e6ac1db1c0 61 fields · synced Jul 12, 2026
- EUDAMED b669a56b-666f-4057-98fd-74f372e9f49c 61 fields · synced Jul 15, 2026
- FDA 510(k) K182340 1 fields · synced May 18, 2026