HomeCanadaBatrik Medical Manufacturing, Inc.

Batrik Medical Manufacturing, Inc.

Canada · Lachine QC · www.batrik.com
✓ Record-verifiedregistrations found in 9 marketsEU SRN CA-MF-000007738

This company has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Canada, Australia, Hong Kong, Israel — 9 overseas markets. EU UDI-DI records ≥300, the first 300 verified individually. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
≥300UDI-DI device records
Class I 238Class IIa 62
large result set — only the first 300 records were verified, so the real figure is at least this
USUnited StatesFDA openFDA
18listed device types
Class I 17Class II 1Class III 0
plus 18 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
38registered device records
Class I 30Class IIa 8
BRBrazilANVISA
1registered devices
Class II 1
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
10registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
1active device licences
Class II 1
6 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
7active ARTG entries
Class I 5IIa 2
HKHong KongMDACS
2valid listings
Class II 2
ILIsraelAMAR
2registrations
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

European Union1,136 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified
United States18 registration records, 1 510(k), 0 PMA
United Kingdom38 confirmed, 0 excluded
Brazil1 confirmed, 0 excluded
Saudi Arabia10 confirmed, 0 excluded
Canada1 confirmed, 0 excluded
Manufacturer names merged into this page: BATRIK MEDICAL MANUFACTURING INC. · BATRIK MEDICAL MANUFACTURING INC · BATRIK Medical Manufacturing Inc · BATRIK MEDICAL MANUFACTURER Inc.

Regulatory identity

EU manufacturer SRN
CA-MF-000007738
EU authorised representative
Advena Limited
UK responsible person
Advena Ltd

Company information

Country
Canada
City
Lachine QC
Website
www.batrik.com
Product categories
Integrated Care, Rehabilitation & HomecareConsumables, disposables & infection control

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Legal name
BATRIK MEDICAL MANUFACTURING INC.
Corporation number
3198189
Registration status
Active
Legal form
Canada Business Corporations Act
Incorporated
1996-03-19

Business registration data from Corporations Canada, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

12024 · K231822

FDA listed device types

showing 8 of 18
Marker, Skin 1Pad, Eye 1Instrument, Ligature Passing And Knot Tying 1Accessories, Cleaning Brushes, For Endoscope 1Stand, Infusion 1Accessory, Surgical Apparel 1Endoscopic Bite Block 1Instrument, Surgical, Disposable 1

Registration details (sample)

MarketIdentifierNameClass / date
EU00690521019072Class IIa
EU00690521023437Class I
EU00690521026162Class I
EU00690521026179Class I
UK64493Anti-Fatigue MatsClass I
UK15778Clamp Jaw CoversClass IIa
UK15778Clamp Jaw CoversClass IIa
USK231822GOLFF Sterile Anti-Fog Solution2024-02-26
BR80153039010LAÇOS VASCULARES MONTSERRATClass II
SAME0000001917SFDAA00183INSTRUMENT PROTECTORS
SAME0000001917SFDAA00182ID TAPE
CA104941KRYSTAL VIEW STERILE ULTRASOUND GELClass II

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