← Back to catalogue
Sterilization Tray, Manipulation Tool
EUDAMEDFDA UDIClass I (EU MDR)
Ref NN-7019Model NICO BrainPath
Identity
- Trade Name
- NICO BrainPath FDA UDI
- Generic Name
- Device sterilization/disinfection container, reusable FDA UDI
- Device Name
- Sterilization Tray, Manipulation Tool EUDAMEDSterilization Tray FDA UDI
- Model / Reference
- NICO BrainPath EUDAMEDNN-7019 EUDAMEDFDA UDI
- Description
- Sterilization Tray FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816744027193 EUDAMEDFDA UDI
- Basic UDI-DI
- 081674402BP6DL EUDAMED
- FDA Product Code
- KCT FDA UDI
- EMDN Code
- Z12011380 CLEANING, DISINFECTION AND STERILISATION INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Device sterilization/disinfection container, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6850 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Sterilization Tray, Manipulation Tool by NICO Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 081674402BP6DL | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- NICO Corporation
- EUDAMED SRN
- US-MF-000000769
- Authorised Representative
- Atlantico Systems, Ltd. IE-AR-000000208
Sources (2)
- EUDAMED 5ae4eda6-396c-4f04-b148-0208dcf0b43e 61 fields · synced Sep 18, 2026
- FDA UDI 826eaab8-063b-4f78-a1ef-2ef3db2abcec 34 fields · synced May 29, 2026