Identity
- Trade Name
- Exicycler™ V5 384 EUDAMEDFDA UDIExicycler™ V5 384 Fast FDA UDI
- Generic Name
- Thermal cycler nucleic acid amplification analyser IVD, laboratory FDA UDI
- Device Name
- ExiCycler™ V5 EUDAMED
- Model / Reference
- A-2065-3 EUDAMEDFDA UDIA-2065-4 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809537078436 EUDAMEDFDA UDI08809537078443 FDA UDI
- Basic UDI-DI
- 880953707A20656V EUDAMED
- FDA Product Code
- OOI FDA UDI
- EMDN Code
- W02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS EUDAMED
- GMDN Term
- Thermal cycler nucleic acid amplification analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 862.2570 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
No
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
Yes
New Device
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Thermal cycler nucleic acid amplification analyser IVD, laboratory
Exicycler™ V5 384 Fast by Bioneer Corporation — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Bioneer Corporation
Sources (3)
- FDA UDI 0d87ff62-78d2-44c9-b92c-c702d4878413 32 fields · synced Jul 9, 2026
- FDA UDI ac7ec322-e0f4-405b-9b0a-874564956bd8 32 fields · synced May 30, 2026
- EUDAMED 1063b56c-869a-41ea-8ee2-36434e175be8 61 fields · synced Jul 9, 2026