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Tianchang Jiarui Packaging Material Co., Ltd.

China · Tianchang Anhui · www.cncarate.com

✓ Record-verifiedregistrations found in 5 marketsEU SRN CN-MF-000012390

This company has registrations in European Union, United States, United Kingdom, Israel, Russia — 5 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

28UDI-DI device records

Class I 2Class IIb 26

USUnited StatesFDA openFDA

7listed device types

Class I 3Class II 4Class III 0

plus 8 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

4registered device records

Class I 3Class IIb 1

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

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

1active registrations

Class 1 1

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.

European Union89 raw hits, 61 excluded, 28 confirmed

United States8 registration records, 2 510(k), 0 PMA, 1 excluded

United Kingdom4 confirmed, 1 excluded

Manufacturer names merged into this page: TIANCHANG JIARUI PACKAGING MATERIAL CO., LTD.

Regulatory identity

EU manufacturer SRN: CN-MF-000012390
EU authorised representative: Everbiz GmbH
UK responsible person: SUNGO Certification Company Limited

FDA 510(k) clearances by year

12017 · K162258

12019 · K181957

FDA listed device types

Absorber, Saliva, Paper 1Shield, Protective, Personnel 1Holder, Film, X-Ray 1Wrap, Sterilization 1Mask, Surgical 1Indicator, Physical/Chemical Sterilization Process 1Drape, Surgical, Exempt 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	16974347938566	safe+sound health	Class I
EU	06979221081379	—	Class IIb
EU	06979221081362	—	Class IIb
EU	06979221081355	—	Class IIb
UK	58749	Silicone Tape	Class I
UK	44898	Silicone Scar Gel	Class I
UK	46854	Polyurethane Dressings	Class IIb
US	K181957	Heat Sealing Sterilization Pouch Flat, Heat Sealing Sterilization Pouch Gusseted, Heat Sealing Sterilization Pouch Roll Flat, Heat Sealing Sterilization Pouch Roll Gusseted	2019-07-09
US	K162258	Self Sealing Sterilization Pouches	2017-04-28

Tianchang Jiarui Packaging Material Co., Ltd.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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