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Cartuccia Con 36 Pozzetti/36-Wells Cartridge
EUDAMEDFDA UDIClass A (EU MDR)
Ref HyCT36.01-25Model HyCT16.01-25
by Hyris Srl
Identity
- Trade Name
- CARTUCCIA CON 36 POZZETTI/36-WELLS CARTRIDGE EUDAMEDFDA UDI
- Generic Name
- Instrument/analyser specimen/reagent container carrier IVD FDA UDI
- Device Name
- CARTUCCIA CON 16 POZZETTI/16-WELLS CARTRIDGE EUDAMEDPCR Cartridge. FDA UDI
- Model / Reference
- HyCT16.01-25 EUDAMEDHyCT36.01-25 EUDAMEDFDA UDI
- Description
- PCR Cartridge. FDA UDI
Identifiers
- Catalog Number
- HyCT36.01-25 FDA UDI
- Primary DI / UDI-DI
- 80575074300302 EUDAMED08057507430030 FDA UDI
- Basic UDI-DI
- 805750743HYCTHN EUDAMED
- FDA Product Code
- NSU FDA UDI
- EMDN Code
- W02050185 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES EUDAMED
- GMDN Term
- Instrument/analyser specimen/reagent container carrier IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 862.2570 FDA UDI
- Market of Registration
- Italy 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
Yes
EUDAMED
New Device
No
EUDAMED
Prescription Use
No
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 UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Cartuccia Con 36 Pozzetti/36-Wells Cartridge by Hyris Srl — 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 | 805750743HYCTHN | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Hyris Srl
- EUDAMED SRN
- IT-MF-000031635
Sources (2)
- EUDAMED b85c0369-0b33-47e8-843a-e0a27cd35de1 61 fields · synced Oct 6, 2026
- FDA UDI 9ddecc8a-e49e-4034-9a31-152e05578fe3 34 fields · synced May 30, 2026