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Xinle Huabao Medical Products Co., Ltd.

✓ Record-verifiedregistrations found in 5 marketsEU SRN CN-MF-000008893Unified social credit code 91130184721655816N

This company holds 6 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Australia — 4 overseas markets.

Registrations by market

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

CNChinaNMPA

6China registrations

Class I 5Class II 1

as of 2026-09-04

EUEuropean UnionEUDAMED

162UDI-DI device records

Class I 162

USUnited StatesFDA openFDA

3listed device types

Class I 2Class II 1Class III 0

plus 3 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

6registered device records

Class I 6

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

1active ARTG entries

Class I 1

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.

European Union162 raw hits, 0 excluded, 162 confirmed

United States3 registration records, 0 510(k), 0 PMA

China6 certificates (Class III 0 / II 1 / I 5), as of 2026-09-04

United Kingdom6 confirmed, 0 excluded

Manufacturer names merged into this page: XINLE HUABAO MEDICAL DEVICES CO.,LTD · XINLE HUABAO MEDICAL PRODUCTS CO., LTD.

Regulatory identity

EU manufacturer SRN: CN-MF-000008893
EU authorised representative: SUNGO Europe B.V.
UK responsible person: SUNGO Certification Company Limited
Unified social credit code: 91130184721655816N
Exhibition record: CMEF 93rd (Apr 2026, Shanghai)

Business registration

Registration status: Active
Incorporated: 1998-04-14
Registered capital: CNY 5,272,716
Paid-in capital: CNY 5,272,716
Legal form: Limited liability company (natural-person invested or controlled)
Industry classification: Rubber and plastic products
Last approval date: 2023-09-08
Recognitions: Micro and small enterpriseNational High-Tech EnterpriseSRDI SME

Business registration data from Tianyancha, as of 2026-09-02. Public registry information only; legal representative and contact-person details are not collected. The figure is the number of employees enrolled in social insurance as declared by the company, which may differ from actual headcount.

Registration details (sample)

Market	Identifier	Name	Class / date
CN	冀械注准20222140235	一次性使用无菌手术包	Class II
CN	冀石械备20220515	医用隔离鞋套	Class I
CN	冀石械备20210012号	医用垫单	Class I
CN	冀石械备20200123号	PE隔离衣	Class I
EU	06974802581255	EXCELLENT GREEN SHIELD	Class I
EU	16974802581351	EXCELLENT GREEN SHIELD	Class I
EU	06974802581354	EXCELLENT GREEN SHIELD	Class I
EU	16974802581344	EXCELLENT GREEN SHIELD	Class I
UK	35492	Sterile Non-woven and PE Composited Isolation Gowns	Class I
UK	35492	Non-Sterile Cover Gowns	Class I
UK	47783	Sterile Non-woven Surgical Drapes	Class I

Xinle Huabao Medical Products Co., Ltd.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

FDA listed device types

Registration details (sample)

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