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Nanjing 3H Medical Product Co., Ltd

China · Nanjing Jiangsu · www.3hcorp.com

✓ Record-verifiedregistrations found in 8 marketsEU SRN CN-MF-000002303Unified social credit code 91320118793737378R

This company holds 65 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Taiwan, Australia, Russia — 7 overseas markets. EU UDI-DI records ≥300, the first 300 verified individually.

Registrations by market

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

CNChinaNMPA

65China registrations

Class I 55Class II 10

as of 2026-09-04

EUEuropean UnionEUDAMED

≥300UDI-DI device records

Class I 300

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

24listed device types

Class I 23Class II 1Class III 0

plus 24 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

9registered device records

Class I 9

BRBrazilANVISA

22registered devices

Class I 22

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

5valid device licences

Class I 5

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

12active ARTG entries

Class I 12

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

4active registrations

Class 1 4

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 Union561 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified

United States24 registration records, 1 510(k), 0 PMA, 4 excluded

China65 certificates (Class III 0 / II 10 / I 55), as of 2026-09-04

United Kingdom9 confirmed, 0 excluded

Brazil22 confirmed, 0 excluded

Manufacturer names merged into this page: NANJING 3H MEDICAL PRODUCTS CO.,LTD. · 3H Medical Corporation · NANJING 3H MEDICAL PRODUCTS CO. LTD. · NANJING 3H MEDICAL PRODUCTS CO, LTD.

Regulatory identity

EU manufacturer SRN: CN-MF-000002303
EU authorised representative: Lotus NL B.V.
UK responsible person: SUNGO Certification Company Limited
Unified social credit code: 91320118793737378R
Exhibition record: CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Business registration

Registration status: Active
Incorporated: 2006-12-01
Registered capital: CNY 10,000,000
Paid-in capital: CNY 10,000,000
Legal form: Limited liability company (natural-person invested or controlled)
Industry classification: Software and IT services
Last approval date: 2024-12-19
Recognitions: National High-Tech EnterpriseTechnology-based SMESRDI SMEGazelle enterpriseInnovative 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.

FDA 510(k) clearances by year

12021 · K211295

FDA listed device types

showing 8 of 24

Adhesive Backed Thermal Skin Patches 1First Aid Kit Without Drug 1Dressing, Wound, Occlusive 1Orthosis, Limb Brace 1Bag, Ice 1Bath, Sitz, Nonpowered 1Chair And Table, Medical 1Dressing, Compression 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	苏械注准20262140552	一次性使用创口贴	Class II
CN	苏械注准20262140545	透明质酸钠凝胶敷料	Class II
CN	苏械注准20252142212	藻酸盐敷料	Class II
CN	苏械注准20252142028	凝胶敷料	Class II
EU	06979191884826	NEW Cotton Poly Athletic Tape with Fine Zig-Zag Edge and Zinc Oxide	Class I
EU	06979191884819	Kinesiology Tape	Class I
EU	06979191884802	Kinesiology Tape	Class I
EU	06979191884796	Kinesiology Tape	Class I
UK	16866	Tape	Class I
UK	16866	Plaster	Class I
UK	16866	plaster	Class I
US	K211295	Surgical Mask (sterile)	2021-11-24
BR	10332820017	Kinesio Tape Ciex - Bandagem Adesiva Elástica	Class I
BR	80676130062	BANDAGEM UNDERWRAP FOAM WRAP	Class I
BR	80718470031	EVO TAPE UNDERWRAP	Class I

Nanjing 3H Medical Product Co., Ltd

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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