# EXABLATE 2100 Type 1.0/1.1/1.11

> Active: European Union. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/exablate-exablate-2100>
- Manufacturer: [Insightec Ltd](https://devicerts.com/manufacturers/insightec-ltd) (Israel)
- Device class: Class IIb (EU MDR); Class III (US FDA)
- FDA product code: LSY, NRZ, PLP
- EMDN: Z120610 ULTRASOUND THERAPY EQUIPMENT
- GMDN: Therapeutic oncological/gynaecological ultrasound system (57888)

## Registrations and authorizations

- **EUDAMED** · CE/MDR · European Union · Basic UDI-DI 7290015461Ex2100V1T3SYS32 · UDI-DI 07290015461016 · registered 2026-08-04 · status: Active
- **EUDAMED** · CE/MDR · European Union · 3902589CE01 · issued 2026-02-01 · expires 2031-02-01 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI 07290015461016 · listed 2016-08-03 · status: Listed (GUDID: in commercial distribution)

## EU certificates

- 3902589CE01 · Quality management system · MDR · notified body DEKRA Certification B.V. · issued 2026-02-01 · expires 2031-02-01 · status: reissued

## Recalls

No recall on record.

## Identity

- Trade name: Exablate 2100V1 [EUDAMED]; EXABLATE [FDA GUDID (AccessGUDID)]
- Generic name: Therapeutic oncological/gynaecological ultrasound system [FDA GUDID (AccessGUDID)]
- Device name: Exablate System 2100V1 Type 3.0 [EUDAMED]
- Model / Ref / Catalog: 2100V1 [EUDAMED]; 2100V1 Type 3.0 [EUDAMED]; 2100 Type 1.0/1.1/1.11 [FDA GUDID (AccessGUDID)]; EXABLATE 2100 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 07290015461016 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: 7290015461Ex2100V1T3SYS32 [EUDAMED]
- FDA product code: LSY [FDA GUDID (AccessGUDID)]; NRZ [FDA GUDID (AccessGUDID)]; PLP [FDA GUDID (AccessGUDID)]
- EMDN code: Z120610 [EUDAMED]
- GMDN term: Therapeutic oncological/gynaecological ultrasound system (57888) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class IIb [EUDAMED]; Class III [FDA GUDID (AccessGUDID)]
- Regulation number: 876.4340 [FDA GUDID (AccessGUDID)]
- System or procedure pack: System which is a device in itself [EUDAMED]
- EU registration type: Standard device [EUDAMED]
- EU market of registration: Germany [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Clinical & Handling

- MRI safety: MR Safe [FDA GUDID (AccessGUDID)]

## Dimensions & Sizes

- Size: Weight — 890 Kilogram [FDA GUDID (AccessGUDID)]

## Properties

- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Serial number: Yes [FDA GUDID (AccessGUDID)]
- Manufacturing date: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Sterilise before use: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reusable: No [EUDAMED]
- Contains latex: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reprocessed single-use device: No [EUDAMED]
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No [EUDAMED]
- Incorporates a substance derived from human blood or plasma: No [EUDAMED]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Contains endocrine-disrupting substances: No [EUDAMED]
- Administering medicine: No [EUDAMED]
- Measuring function: No [EUDAMED]
- Incorporates a medicinal substance: No [EUDAMED]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Lot / batch number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: EXABLATE 2100 Type 1.0/1.1/1.11, Insightec Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/exablate-exablate-2100 (data as of 2026-11-15).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [EUDAMED](https://ec.europa.eu/tools/eudamed)
- Registry records last synced: 2026-11-12
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/exablate-exablate-2100.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/exablate-exablate-2100
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.