Identity
- Trade Name
- Cuvette Arcs EUDAMEDNOVEOS Cuvette Arc Pack FDA UDI
- Generic Name
- Assay container IVD, reusable FDA UDI
- Device Name
- NOVEOS® Immunoassay System Accessories EUDAMED
- Model / Reference
- 117450-001 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816879023114 EUDAMEDFDA UDI
- Basic UDI-DI
- 081687902NOVACCKX EUDAMED
- 510(k) Number
- K182479 FDA UDI
- FDA Product Code
- DHB FDA UDIJJE FDA UDI
- EMDN Code
- W0201020185 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES EUDAMED
- GMDN Term
- Assay container IVD, reusable FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 866.5750 FDA UDI862.2160 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Cuvette Arcs by Hycor Biomedical Llc — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 081687902NOVACCKX | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Hycor Biomedical LLC
- EUDAMED SRN
- US-MF-000031449
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 98333a73-6ded-4429-9566-0267f289a9b6 61 fields · synced Jun 18, 2026
- FDA UDI e46f04b0-a323-49cd-bc29-d5c5a6d04ce5 34 fields · synced May 30, 2026