Health Canada licence record
Licence 115863
Medical device licence on Health Canada’s active licence listing (MDALL). Class IV. Status D, which the register defines as Issued/Conditional. First issued 29 July 2026.
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 | 115863 | original_licence_no |
| Licence status | D (Issued/Conditional) | licence_status |
| Application risk class | 4 | appl_risk_class |
| Licence name | GLOBE PULSED FIELD SYSTEM | licence_name |
| Licence name, French | GLOBE PULSED FIELD SYSTEM | licence_name_fr |
| Date of the first issued licence | 2026-07-29 | first_licence_status_dt |
| Date of cancellation | null | end_date |
| Licence type | System | licence_type_desc |
| Company identification number | 130189 | company_id |
Source: Health Canada MDALL, licence 115863, API record retrieved 2026-10-10 22:15 Eastern. Status codes as defined in the MDALL API guide.
The licence holder as the register records it. The company page lists every licence under this identification number.
KARDIUM INC.
155-8518 Glenlyon Pkwy
Burnaby BC V5J 0B6, CA
Company status A
Resolution
No verified alias in ArrHub’s table; the name stands as the register spells it.
Each device the register lists under licence 115863, 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 |
|---|---|---|---|
| 1015484JSON | GLOBE CATHETER | 2026-07-29 | null |
| 1015485JSON | GLOBE CONTROLLER | 2026-07-29 | null |
| 1015487JSON | GLOBE SOFTWARE | 2026-07-29 | null |
| 1015488JSON | GLOBE CATHETER CABLE | 2026-07-29 | null |
| 1015490JSON | GLOBE INTRODUCER | 2026-07-29 | null |
| 1025886JSON | GLOBE WORKSTATION | 2026-07-29 | null |
| 1025887JSON | GLOBE POSITIONING SYSTEM CABLE | 2026-07-29 | null |
| 1025889JSON | GLOBE POSITIONING SYSTEM ELECTRODES | 2026-07-29 | null |
| 1088328JSON | GLOBE PULSED FIELD GENERATOR | 2026-07-29 | null |
| 1088329JSON | GLOBE LOADER PLUG | 2026-07-29 | null |
Source: Health Canada MDALL, device records for licence 115863, retrieved 2026-10-10 22:15 Eastern. Device identifiers link to the agency’s device record.
Regulatory Decision Summaries Health Canada has published for this licence, newest first. Each links to the agency’s record.
New device licence application with conditions, application 406447
Decision date 2026-07-29. Filed 2025-12-12.
Prints 1 term and condition:
Source: Health Canada, Drug and Health Product Register, Regulatory Decision Summaries, retrieved 2026-10-10 22:15 Eastern. Terms and conditions as the summary prints them.
What ArrHub adds to the record. Everything above this line is the agency’s; everything here is ArrHub’s, dated and attributed.
Electrophysiology
Confirmed by review, before 24 September 2026; the review record carries no timestamp.
FDA record pair
P240044PMA original, product code QZI. FDA decision 27 August 2025. Pair confirmed under the verification protocol by product name, human review, 24 September 2026; reference class pfa_system.
336
Days from the FDA decision to the first issued Canadian licence. Computed from the two dates.
First seen by ArrHub’s weekly snapshot: 2026-09-20 09:05 Eastern.
The stored record exactly as ArrHub holds it, for anyone who wants to check the page against it.
{
"original_licence_no": 115863,
"licence_status": "D",
"licence_status_desc": "Issued/Conditional",
"appl_risk_class": 4,
"licence_name": "GLOBE PULSED FIELD SYSTEM",
"licence_name_fr": "GLOBE PULSED FIELD SYSTEM",
"first_licence_status_dt": "2026-07-29",
"end_date": null,
"licence_type_desc": "System",
"company_id": 130189,
"company_name": "KARDIUM INC.",
"country_cd": "CA",
"city": "Burnaby",
"source_url": "https://health-products.canada.ca/api/medical-devices/licence/?id=115863&lang=en&type=json",
"verified_at": "2026-09-20T02:17:32.098823+00:00",
"ep_confirmed_at": null,
"collected_at": "2026-10-11T02:15:33.877+00:00",
"last_checked_at": "2026-10-11T02:15:33.877+00:00",
"record_url": "https://health-products.canada.ca/mdall-limh/information?licenceId=115863&type=active&lang=eng",
"company_record_url": "https://health-products.canada.ca/mdall-limh/information?companyId=130189&lang=eng"
}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.
Contains information licensed under the Open Government Licence – Canada.
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