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Merz North America, Inc.

USA · Franksville

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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

15listed device types

Class I 6Class II 6Class III 3

plus 37 registration records and 1 510(k), 463 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

2 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

7active device licences

Class II 3Class III 4

12 including historic records

TWTaiwanTFDA

2valid device licences

Class III 2

SGSingaporeHSA SMDR

2device registrations

CLASS D 1D WITH MEDICINAL PRODUCT 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

2active ARTG entries

Class III 2

HKHong KongMDACS

2valid listings

Class IV 2

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

2active registrations

Class 3 2

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 States37 registration records, 1 510(k), 463 PMA, 6 excluded

Brazil0 confirmed, 1 excluded

Canada7 confirmed, 1 excluded

Manufacturer names merged into this page: Merz North America, Inc. · MERZ NORTH AMERICA, INC.

FDA 510(k) clearances by year

12017 · K172689

FDA listed device types

showing 8 of 15

Implant, Dermal, For Aesthetic Use In The Hands 1Implant, Dermal, For Aesthetic Use 1Agent, Bulking, Injectable For Gastro-Urology Use 1Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) 1System, Imaging, Pulsed Echo, Ultrasonic 1System, Vocal Cord Medialization 1Transparent Patch For Use In Treatment Of Tattoos 1Powered Surgical Instrument For Improvement In The Appearance Of Cellulite 1

Market	Identifier	Name	Class / date
US	K172689	DESCRIBE PFD Patch	2017-11-29
CA	35509	INJECTION CATHETER ACCESSORY	Class II
CA	69052	RADIESSE INJECTABLE IMPLANT	Class III
CA	75906	LOW VISCOSITY CAHA IMPLANT	Class III

Merz North America, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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