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Home›USA›DSM BIOMEDICAL, INC. D.B.A. DSM BIOMEDICAL

DSM BIOMEDICAL, INC. D.B.A. DSM BIOMEDICAL

USA · Exton
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, South Korea — 3 overseas markets. 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
pendingnot queried
USUnited StatesFDA openFDA
29listed device types
Class I 2Class II 25Class III 1unclassified 1
plus 56 registration records and 10 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
3active device licences
Class III 1Class IV 2
15 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
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.

United States56 registration records, 10 510(k), 0 PMA, 1 excluded
Brazil0 confirmed, 2 excluded
Canada3 confirmed, 0 excluded
Manufacturer names merged into this page: DSM Biomedical, Inc. · DSM BIOMEDICAL, INC. D.B.A. DSM BIOMEDICAL
Same-named companies — This database also contains companies with near-identical names: DSM Biomedical, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Exton

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.

FDA 510(k) clearances by year

22013
22015
12016
12017
22018
12020
12023

FDA listed device types

showing 8 of 29
Bone Grafting Material, Animal Source 1Screw, Fixation, Bone 1Mesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction 1Mesh, Surgical, Collagen, Staple Line Reinforcement 1Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed 1Fastener, Fixation, Biodegradable, Soft Tissue 1Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair 1Pin, Fixation, Smooth 1

Registration details (sample)

MarketIdentifierNameClass / date
USK230054DSM Biomedical Calcium Phosphate Cement2023-03-21
USK193212DSM Biomedical Dental Bone Graft Plus2020-09-10
USK173572DSM Biomedical Calcium Phosphate Cement with Microspheres2018-05-09
CA2375DRILAC SURGICAL DRESSINGSClass III
CA74184QUICKCAT EXTRACTION CATHETER SYSTEMClass IV
CA77607THROMCAT THROMBECTOMY CATHETER SYSTEMClass IV

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