ABBOTT MEDICAL
One St. Jude Medical Drive
St. Paul MN 55117, US
Company status A
Health Canada licence record
Licence 106121
ENSITE X EP SYSTEM
Medical device licence on Health Canada’s active licence listing (MDALL). Class III. Status I, which the register defines as Issued/Active. First issued 12 May 2021.
Licence
Each row is one field of the agency record. The grey name beside the label is the field’s name in the agency’s own documentation.
| Field | Value | Field name |
|---|---|---|
| Licence number | 106121 | original_licence_no |
| Licence status | I (Issued/Active) | licence_status |
| Application risk class | 3 | appl_risk_class |
| Licence name | ENSITE X EP SYSTEM | licence_name |
| Licence name, French | ENSITE X EP SYSTEM | licence_name_fr |
| Date of the first issued licence | 2021-05-12 | first_licence_status_dt |
| Date of cancellation | null | end_date |
| Licence type | System | licence_type_desc |
| Company identification number | 148249 | company_id |
Source: Health Canada MDALL, licence 106121, API record retrieved 2026-10-17 22:15 Eastern. Status codes as defined in the MDALL API guide.
Company
The licence holder as the register records it. The company page lists every licence under this identification number.
Resolved to
Abbott
The register name above is resolved to its organisation under ArrHub’s alias table. Method: rule:prefix. Source: fda_applicant. Verified 20 September 2026.
Devices on this licence
Each device the register lists under licence 106121, with the date it was added. Later additions do not change the date of the first issued licence.
| Device ID | Trade name | Added to licence | Removed |
|---|---|---|---|
| 1027524JSON | ENSITE X EP SYSTEM AMPERE CONNECT CABLE | 2021-05-12 | null |
| 1027525JSON | ENSITE X EP SYSTEM AMPLIFIER | 2021-05-12 | null |
| 1027526JSON | ENSITE X EP SYSTEM AMPLIFIER POWER MODULE | 2021-05-12 | null |
| 1027527JSON | ENSITE X EP SYSTEM WORKMATE CLARIS ECG CABLE | 2021-05-12 | null |
| 1027528JSON | ENSITE X EP SYSTEM CATHETER INPUT MODULE | 2021-05-12 | null |
| 1027529JSON | ENSITE X EP SYSTEM DISPLAY WORKSTATION | 2021-05-12 | null |
| 1027530JSON | ENSITE X EP SYSTEM FIELD FRAME | 2021-05-12 | null |
| 1027531JSON | ENSITE X EP SYSTEM FIELD FRAME CABLE | 2021-05-12 | null |
| 1027532JSON | ENSITE X EP SYSTEM PATIENT REFERENCE SENSOR 3 | 2021-05-12 | null |
| 1027533JSON | ENSITE X EP SYSTEM PATIENT REFERENCE SENSOR 1 | 2021-05-12 | null |
| 1027534JSON | ENSITE X EP SYSTEM WORKMATE CLARIS CABLE IC56 | 2021-05-12 | null |
| 1027535JSON | ENSITE X EP SYSTEM WORKMATE CLARIS CABLE IC64 | 2021-05-12 | null |
| 1027536JSON | ENSITE X EP SYSTEM RADIO-LUCENT ECG CABLE | 2021-05-12 | null |
| 1027538JSON | ENSITE X EP SYSTEM RADIO-OPAQUE ECG CABLE | 2021-05-12 | null |
| 1027539JSON | ENSITE X EP SYSTEM SURFACELINK MODULE | 2021-05-12 | null |
| 1027540JSON | ENSITE X EP SYSTEM ECG OUTPUT MODULE | 2021-05-12 | null |
| 1027541JSON | ENSITE X EP SYSTEM RECORDING SYSTEM IC OUTPUT CABLE | 2021-05-12 | null |
| 1034050JSON | ENSITE X EP SYSTEM SOFTWARE UPGRADE | 2021-10-20 | null |
| 1050696JSON | ENSITE X EP SYSTEM, TACTIFLEX ABLATION CATHETER, SENSOR ENABLED, SOFTWARE UPGRADE | 2023-09-06 | null |
| 1069814JSON | ENSITE X AMPLIFIER AIR FILTER | 2024-10-07 | null |
| 1087055JSON | ENSITE X EP SYSTEM PFA GENERATOR CONNECT CABLE | 2026-04-16 | null |
| 1087056JSON | ENSITE X EP SYSTEM SYSTEM CATHETER CONNECTOR CABLE | 2026-04-16 | null |
| 1087057JSON | ENSITE X EP SYSTEM SYSTEM CABLE KIT | 2026-04-16 | null |
| 1087058JSON | ENSITE X EP SYSTEM SYSTEM UPGRADE KIT | 2026-04-16 | null |
Source: Health Canada MDALL, device records for licence 106121, retrieved 2026-10-17 22:15 Eastern. Device identifiers link to the agency’s device record.
Decision summaries
Regulatory Decision Summaries Health Canada has published for this licence, newest first. Each links to the agency’s record.
No regulatory decision summary is held for this licence.
Source: Health Canada, Drug and Health Product Register, Regulatory Decision Summaries, retrieved 2026-10-17 22:15 Eastern. Terms and conditions as the summary prints them.
ArrHub
What ArrHub adds to the record. Everything above this line is the agency’s; everything here is ArrHub’s, dated and attributed.
Electrophysiology
Classified against the published categories, 18 October 2026.
First seen by ArrHub’s weekly snapshot: 2026-09-20 09:05 Eastern.
Raw record
The stored record exactly as ArrHub holds it, for anyone who wants to check the page against it.
Show the raw record (JSON)api/medical-devices/licence/?id=106121&lang=en&type=json
{
"original_licence_no": 106121,
"licence_status": "I",
"licence_status_desc": "Issued/Active",
"appl_risk_class": 3,
"licence_name": "ENSITE X EP SYSTEM",
"licence_name_fr": "ENSITE X EP SYSTEM",
"first_licence_status_dt": "2021-05-12",
"end_date": null,
"licence_type_desc": "System",
"company_id": 148249,
"company_name": "ABBOTT MEDICAL",
"country_cd": "US",
"city": "St. Paul",
"source_url": "https://health-products.canada.ca/api/medical-devices/licence/?id=106121&lang=en&type=json",
"verified_at": "2026-09-20T02:17:29.236013+00:00",
"ep_confirmed_at": "2026-10-18T00:00:00+00:00",
"collected_at": "2026-10-18T02:15:32.83+00:00",
"last_checked_at": "2026-10-18T02:15:32.83+00:00",
"record_url": "https://health-products.canada.ca/mdall-limh/information?licenceId=106121&type=active&lang=eng",
"company_record_url": "https://health-products.canada.ca/mdall-limh/information?companyId=148249&lang=eng",
"ep_confirmed_method": "rule"
}The readable page is rendered from the record held in ArrHub’s verified view; the agency record at health-products.canada.ca governs where they differ.
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