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恺硕生物科技（厦门）有限公司

China

✓ Record-verifiedregistrations found in 1 markets

This company holds 25 NMPA certificates in China.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

25China registrations

Class I 25

as of 2026-09-04

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

pendingnot queried

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

pendingnot queried

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

pendingnot queried

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

CACanadaMDALL

pendingnot queried

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.

China25 certificates (Class III 0 / II 0 / I 25), as of 2026-09-04

Registration details (sample)

Market	Identifier	Name	Class / date
CN	闽厦械备20260033	核酸提取试剂	Class I
CN	闽厦械备20250495	甲基化检测样本前处理试剂	Class I
CN	闽厦械备20250443	核酸提取试剂	Class I
CN	闽厦械备20250442	核酸提取试剂	Class I

恺硕生物科技（厦门）有限公司

Registrations by market

How these numbers were verified

Company information

Registration details (sample)

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