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Battery Charger for Optune Lua

FDA UDIEUDAMED

Class III (US FDA UDI)

by Novocure Inc

Identity

Trade Name
Battery Charger for Optune Lua FDA UDI
Generic Name
Alternating electric field antimitotic cancer treatment system generator FDA UDI
Model / Reference
ICH9200 FDA UDI

Identifiers

Catalog Number
ICH9200US FDA UDI
Primary DI / UDI-DI
07290107983211 FDA UDI
PMA Number
H180002 FDA UDI
P230042 FDA UDI
FDA Product Code
QGZ FDA UDI
SDA FDA UDI
GMDN Term
Alternating electric field antimitotic cancer treatment system generator FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Alternating electric field antimitotic cancer treatment system generator

Battery Charger for Optune Lua by Novocure Inc — Class III — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Alternating electric field antimitotic cancer treatment system generator.

Cleared under the same submission

H180002 also covers:

P230042 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Novocure Inc

Sources (2)

  • FDA UDI 4c902766-11ec-4620-921b-3b638029c322 36 fields · synced May 31, 2026
  • EUDAMED 1 fields · synced May 28, 2026