Identity
- Trade Name
- Ion OneTouch™ ES Dx Instrument EUDAMEDIon One Touch™ ES Dx FDA UDI
- Generic Name
- Thermal cycler nucleic acid amplification analyser IVD, laboratory FDA UDI
- Device Name
- Ion Personal Genome Machine (PGM™) Dx Instrument System EUDAMEDION ONE TOUCH ES DX INST FDA UDI
- Model / Reference
- 4485660 EUDAMEDONE TOUCH ES DX FDA UDI
- Description
- ION ONE TOUCH ES DX INST FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10190302000864 EUDAMEDFDA UDI
- Basic UDI-DI
- 0190302A25511RB EUDAMED
- FDA Product Code
- PFF 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
- 862.2265 FDA UDI
- Market of Registration
- Netherlands 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
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Nucleic acid sample preparation instrument IVD
Ion OneTouch™ ES Dx Instrument by Life Technologies Holdings Pte Ltd. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 0190302A25511RB | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Life Technologies Holdings Pte Ltd
- EUDAMED SRN
- SG-MF-000023931
- Authorised Representative
- Life Technologies Europe B.V. NL-AR-000021890
Sources (2)
- EUDAMED e303bb94-3af1-4ca6-b5ed-3ce4a468801d 61 fields · synced Jul 21, 2026
- FDA UDI 7b937530-4c89-4991-a0ea-b8629214e3b4 33 fields · synced May 30, 2026