EMLA (Elekta EVO)

GUDID 07340201503461

Elekta EVO

Elekta Solutions AB

Linear accelerator system

• Primary Device ID: 07340201503461
• NIH Device Record Key: 3a8c1e39-dbe8-4c27-b613-309ba651c50b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EMLA (Elekta EVO)
• Version Model Number: 1571644
• Company DUNS: 353272181
• Company Name: Elekta Solutions AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(855)693-5358
• Email: info.america@elekta.com
• Phone: +1(855)693-5358
• Email: info.america@elekta.com
• Phone: +1(855)693-5358
• Email: info.america@elekta.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07340201503461 [Primary]

FDA Product Code

• IYE: Accelerator, linear, medical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-24
• Device Publish Date: 2026-02-16

Devices Manufactured by Elekta Solutions AB

• 07340201503461 - EMLA (Elekta EVO): 2026-02-24Elekta EVO
• 07340201503461 - EMLA (Elekta EVO): 2026-02-24 Elekta EVO
• 07340201503898 - Leksell GammaPlan: 2026-02-12 Leksell GammaPlan 11.5
• 07340201503782 - AQUA: 2025-12-18 AQUA V3.3 Machine QA Software
• 07340201502273 - Leksell Stereotactic System: 2025-09-25 Post Insulated anterior
• 07340201503317 - Leksell Stereotactic System: 2025-09-25 Instrument Screwdriver, Double
• 07340201502440 - Leksell Stereotactic System: 2025-09-25 Ear Plug Holders
• 07340201502921 - Leksell Stereotactic System: 2025-09-25 Slotted Front Piece
• 07340201502914 - Leksell Stereotactic System: 2025-09-25 Post Insulated posterior long