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Optune HFE transducer array black
FDA UDIEUDAMEDClass III (US FDA UDI)
by Novocure Inc
Identity
- Trade Name
- Optune HFE transducer array black FDA UDI
- Generic Name
- Alternating electric field antimitotic cancer treatment system transducer array FDA UDI
- Model / Reference
- IHEP9020B FDA UDI
Identifiers
- Catalog Number
- IHEP9020BUS FDA UDI
- Primary DI / UDI-DI
- 07290107985888 FDA UDI
- PMA Number
- P100034 FDA UDI
- FDA Product Code
- NZK FDA UDI
- GMDN Term
- Alternating electric field antimitotic cancer treatment system transducer array FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Alternating electric field antimitotic cancer treatment system transducer array
Optune HFE transducer array black by Novocure Inc — Class III — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
P100034 also covers:
- Battery for Optune — NOVOCURE INC
- Battery for Optune — NOVOCURE INC
- Connection Cable for Optune — NOVOCURE INC
- Connection Cable for Optune — NOVOCURE INC
- Connection Cable for Optune — NOVOCURE INC
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- Device Bag for Optune — NOVOCURE INC
- INE Transducer Arrays Tan Plaster and Black Connector — NOVOCURE INC
- INE Transducer Arrays Tan Plaster and Black Connector — NOVOCURE INC
- INE Transducer Arrays Tan Plaster and Black Connector — NOVOCURE INC
- INE Transducer Arrays Tan Plaster and Black Connector — NOVOCURE INC
- INE Transducer Arrays Tan Plaster and White Connector — NOVOCURE INC
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class III | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Novocure Inc
Sources (2)
- FDA UDI 23d9db69-0de8-416f-abab-ae77da3d2c6b 35 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026