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Mayer Laboratories, Inc.

USA · Berkeley

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 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

13listed device types

Class I 6Class II 7Class III 0

plus 25 registration records and 20 510(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

1active device licences

Class III 1

7 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

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 States25 registration records, 20 510(k), 0 PMA

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: MAYER LABORATORIES · MAYER LABORATORIES INC.

FDA 510(k) clearances by year

11987

21988

41989

31990

11993

11994

31995

12001

12011

12012

12013

12026

FDA listed device types

showing 8 of 13

Condom, Synthetic 1 Tampon, Menstrual, Scented, Scented-Deodorized 1Transducer, Ultrasonic, Diagnostic 1Lubricant, Personal 1Condom 1Tampon, Menstrual, Unscented 1Single-Use Internal Condom 1Lubricant, Patient 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252158	Sagami Original 002 Polyurethane Male Condom	2026-03-30
US	K130345	AQUA LUBE NATURAL LUBRICANT - REGULAR, WARMING	2013-08-01
US	K113686	KIMONO MICROTHIN WITH AQUA LUBE, REALITY ULTRA LUBRICATED	2012-03-06
CA	6407	EZ-ON	Class III

Mayer Laboratories, 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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