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EXABLATE 2100 Type 1.0/1.1/1.11

by Insightec Ltd

Ref 2100V1 Type 3.0Model 2100V1

EXABLATE 2100 Type 1.0/1.1/1.11 is a medical device (EU MDR Class IIb; FDA Class III; EMDN category ultrasound therapy equipment) made by Insightec Ltd, registered in EUDAMED on 4 Aug 2026 (Basic UDI-DI 7290015461Ex2100V1T3SYS32) with CE/MDR certificate 3902589CE01 valid until 1 Feb 2031 and listed in FDA GUDID since 3 Aug 2016 (UDI-DI 07290015461016), active as of 12 Nov 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

1 Feb 2031

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier DEKRA Certification B.V.

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number7290015461Ex2100V1T3SYS32 Basic UDI-DI 07290015461016UDI-DIDate4 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290015461016 UDI-DI Date3 Aug 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 7290015461Ex2100V1T3SYS32 registered 4 Aug 2026 Active· +1 more in the status table
  • FDA GUDID UDI-DI 07290015461016 listed 3 Aug 2016 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 3902589CE01 Active Reissued

    Quality management system EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    1 Feb 2026
    Expires
    1 Feb 2031

Timeline

4 dated events

  1. Listed FDA GUDID 07290015461016
  2. Certificate issued EUDAMED 3902589CE01
  3. Registered EUDAMED 7290015461Ex2100V1T3SYS32
  4. Certificate expires EUDAMED 3902589CE01

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Exablate 2100V1 EUDAMED
Exablate GUDID
Generic name
Therapeutic oncological/gynaecological ultrasound system
Device name
Exablate System 2100V1 Type 3.0
Model / Ref / Catalog
2100V1 EUDAMED
2100V1 Type 3.0 EUDAMED
2100 Type 1.0/1.1/1.11 GUDID
EXABLATE 2100 GUDID
Primary DI / UDI-DI
07290015461016
Basic UDI-DI
7290015461Ex2100V1T3SYS32
FDA product code
LSY, NRZ, PLP
EMDN code
Z120610 Ultrasound therapy equipment
GMDN term
Therapeutic oncological/gynaecological ultrasound system
Device class
Class IIb EUDAMED
Class III GUDID
Regulation number
876.4340
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe
Size
Weight — 890 Kilogram

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
2100V1
2100V1 Type 3.0
GUDID
2100 Type 1.0/1.1/1.11
Device classEUDAMED
Class IIb
GUDID
Class III

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class III in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Therapeutic oncological/gynaecological ultrasound system

Similar devices in this category

Other devices filed under ULTRASOUND THERAPY EQUIPMENT.

Other devices from Insightec Ltd

See all devices from Insightec Ltd →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)