AMVIA SKY PACEMAKER

Medical device licence on Health Canada’s active licence listing (MDALL). Class IV. Status I, which the register defines as Issued/Active. First issued 27 March 2024.

Open on Health CanadaAgency recordJSON

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	111005	original_licence_no
Licence status	I (Issued/Active)	licence_status
Application risk class	4	appl_risk_class
Licence name	AMVIA SKY PACEMAKER	licence_name
Licence name, French	AMVIA SKY PACEMAKER	licence_name_fr
Date of the first issued licence	2024-03-27	first_licence_status_dt
Date of cancellation	null	end_date
Licence type	Device Family	licence_type_desc
Company identification number	101632	company_id

Source: Health Canada MDALL, licence 111005, API record retrieved 2026-10-10 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.

BIOTRONIK SE & CO. KG

Woermannkehre 1
Berlin 11 12359, DE

Company status A

All licences held by this companyCompany record on Health Canada

Resolution

No verified alias in ArrHub’s table; the name stands as the register spells it.

Devices on this licence

Each device the register lists under licence 111005, 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
1059666JSON	AMVIA SKY SR-T	2024-03-27	null
1059667JSON	AMVIA SKY DR-T	2024-03-27	null
1059668JSON	AMVIA SKY HF-T	2024-03-27	null
1059669JSON	AMVIA SKY HF-T QP	2024-03-27	null

Source: Health Canada MDALL, device records for licence 111005, retrieved 2026-10-10 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.

RDS14455JSON

New device licence application, application 372522

Decision date 2024-03-27. Filed 2023-12-19.

Prints no terms and conditions.

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.

ArrHub

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.

Record pair

No confirmed pair across the two registers for this record.

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=111005&lang=en&type=json

{
  "original_licence_no": 111005,
  "licence_status": "I",
  "licence_status_desc": "Issued/Active",
  "appl_risk_class": 4,
  "licence_name": "AMVIA SKY PACEMAKER",
  "licence_name_fr": "AMVIA SKY PACEMAKER",
  "first_licence_status_dt": "2024-03-27",
  "end_date": null,
  "licence_type_desc": "Device Family",
  "company_id": 101632,
  "company_name": "BIOTRONIK SE & CO. KG",
  "country_cd": "DE",
  "city": "Berlin",
  "source_url": "https://health-products.canada.ca/api/medical-devices/licence/?id=111005&lang=en&type=json",
  "verified_at": "2026-09-20T02:17:31.71044+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=111005&type=active&lang=eng",
  "company_record_url": "https://health-products.canada.ca/mdall-limh/information?companyId=101632&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.

Links open the agency’s own records. Unlabelled links open web pages. Links marked (JSON) open an agency’s data record, which a browser shows as plain text.

Report a broken link or a record that does not match its source: alerts@arrhub.com. Corrections are published, with their date, at arrhub.com/corrections.