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Xuchang Zhengde Environstar Medical Products Co.,L

China · Guangzhou Guangdong

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 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

pendingnot queried

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

7listed device types

Class I 6Class II 1Class III 0

plus 7 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

21registered devices

Class I 21

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

0active device licences

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 States7 registration records, 3 510(k), 0 PMA, 1 excluded

Brazil21 confirmed, 0 excluded

Manufacturer names merged into this page: XUCHANG ZHENGDE ENVIRONSTAR MEDICAL PRODUCTS CO.,LTD. · XUCHANG ZHENGDE ENVIRONSTAR MEDICAL PRODUCTS CO.,LTD - 461200 · XUCHANG ZHENGDE ENVIRONSTAR MEDICAL PRODUCTS CO. LTD. · Xuchang Zhengde Environstar Medical Products Co., Ltd

Same-named companies — This database also contains companies with near-identical names: Xuchang Zhengde Environstar Medical Products Co., Ltd.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

12015 · K141467

12020 · K192290

12022 · K213893

FDA listed device types

Drape, Surgical, Exempt 1Gauze/Sponge, Internal, X-Ray Detectable 1Accessory, Surgical Apparel 1Non-Surgical Gown 1Fiber, Medical, Absorbent 1Gauze / Sponge,Nonresorbable For External Use 1Bandage, Elastic 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K213893	Comfort Gown, Safewear Gown	2022-12-21
US	K192290	50g SMS Standard Surgical Gown, 45g SMS Surgical Gown with Reinforcement, 68g BVB Surgical Gown, 68g BVB Splicing Surgical Gown	2020-04-30
US	K141467	SURGICAL GOWN	2015-03-05
BR	82730460001	KIT CIRÚRGICO PARA CESÁREA	Class I
BR	82730460002	KIT CIRÚRGICO PARA PARTO/ LITOTOMIA	Class I
BR	82730460003	AVENTAL CIRÚRGICO SMS	Class I

Xuchang Zhengde Environstar Medical Products Co.,L

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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