Identity
- Trade Name
- Idylla™ Instrument EUDAMEDIdylla™ System FDA UDI
- Generic Name
- Thermal cycler nucleic acid amplification analyser IVD, laboratory FDA UDI
- Device Name
- Idylla™ Instrument EUDAMEDUp to eight Idylla™ Instruments and the Idylla™ Console constitute the Idylla™ System. FDA UDI
- Model / Reference
- P0010 EUDAMEDIdylla™ Instrument FDA UDI
- Description
- Up to eight Idylla™ Instruments and the Idylla™ Console constitute the Idylla™ System. FDA UDI
Identifiers
- Catalog Number
- P0010 FDA UDI
- Primary DI / UDI-DI
- 05415219000119 EUDAMEDFDA UDI
- Basic UDI-DI
- 5415219P0010GM 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
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
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 UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Nucleic acid sample preparation instrument IVD
Idylla™ Instrument by Biocartis NV — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nucleic acid sample preparation instrument IVD.
- Applied Biosystems™ SeqStudio™ 24 Flex Dx Genetic Analyzer — Life Technologies Holdings Pte Ltd. · Class A
- TANBead Nucleic Acid Extractor — Taiwan Advanced Nanotech Inc. · Class A
- NC-15Plus(32) — HANWOOLTPC Co., Ltd. · Class A
- 3500 Dx Genetic Analyzer — Life Technologies Holdings Pte Ltd. · Class A
- ALLSHENG — HANGZHOU ALLSHENG INSTRUMENTS CO., LTD. · Class I
- isoQuarkM4 — RevoSketch Inc. · Class A
- Automated Nucleic Acid Extraction and Amplification System — Hybribio Medtech Device Co.,Ltd · Class A
- Real-time PCR system — Hangzhou Bio-gener Technology Co., Ltd. · Class A
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 | 5415219P0010GM | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biocartis NV
- EUDAMED SRN
- BE-MF-000003661
Sources (2)
- EUDAMED b965c376-a01a-4070-ba0c-a0f058b93fc1 61 fields · synced Jun 19, 2026
- FDA UDI d94af444-ec09-42a6-b587-cbbbfdcb5344 34 fields · synced May 30, 2026