Ion PGM™ Dx Sequencer

EUDAMEDFDA UDI

Class A (EU MDR)

Ref 4485656

by Life Technologies Holdings Pte Ltd

Identity

Trade Name: Ion PGM™ Dx Sequencer EUDAMED
Personal Genome Machine™ Dx (PGM™) Dx FDA UDI
Generic Name: Nucleic acid sequence analyser IVD, next-generation sequencing (NGS) FDA UDI
Device Name: Ion Personal Genome Machine (PGM™) Dx Instrument System EUDAMED
Model / Reference: 4485656 EUDAMED
7469 FDA UDI

Identifiers

Primary DI / UDI-DI: 10190302000833 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: Nucleic acid sequence analyser IVD, next-generation sequencing (NGS) FDA UDI

Classification

Device Class: Class A EUDAMED
Class II FDA UDI
Regulation Number: 862.2265 FDA UDI
Market of Registration: Netherlands EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Microbial Substances

EUDAMED

Reagent

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

Yes

EUDAMED

New Device

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Nucleic acid sample preparation instrument IVD

Ion PGM™ Dx Sequencer 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

European Union Active

CE/IVDR

United States Pending data

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 accde3fb-8186-450e-8a51-547b4b47ee7c 61 fields · synced Jun 18, 2026
FDA UDI 9c924801-9d23-4c7b-b036-e71d056e10ad 32 fields · synced May 30, 2026