HomeChinaTRICOL BIOMEDICAL INC

TRICOL BIOMEDICAL INC

China · 潍坊
✓ Record-verifiedregistrations found in 9 marketsEU SRN US-MF-000002003Unified social credit code 913707000590435237

This company holds 22 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Canada, Taiwan, Singapore, Hong Kong, Israel — 8 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
22China registrations
Class I 16Class II 6
as of 2026-09-04
EUEuropean UnionEUDAMED
16UDI-DI device records
Class III 16
USUnited StatesFDA openFDA
5listed device types
Class I 2Class II 1Class III 0unclassified 2
plus 9 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
1registered device records
Class III 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
1active device licences
Class II 1
4 including historic records
TWTaiwanTFDA
2valid device licences
Class II 1Class III 1
SGSingaporeHSA SMDR
1device registrations
CLASS D 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
1valid listings
Class IV 1
ILIsraelAMAR
3registrations
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 Union34 raw hits, 18 excluded, 16 confirmed
United States9 registration records, 1 510(k), 0 PMA
China22 certificates (Class III 0 / II 6 / I 16), as of 2026-09-04
United Kingdom1 confirmed, 0 excluded
Canada1 confirmed, 0 excluded
Manufacturer names merged into this page: Tricol Biomedical, INC. · TRICOL BIOMEDICAL, INC.

Regulatory identity

EU manufacturer SRN
US-MF-000002003
EU authorised representative
AR Experts B.V.
UK responsible person
Qserve Group UK, Ltd.
Unified social credit code
913707000590435237
Exhibition record
CMEF 89th (Apr 2024, Shanghai)

Company information

Country
China
Social-insurance enrolees
190
Annual revenue
RMB 50–100M

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Registration status
Active
Incorporated
2013-02-07
Registered capital
CNY 77,427,500
Paid-in capital
CNY 34,856,900
Legal form
Joint-stock limited company (unlisted, natural-person invested or controlled)
Industry classification
Other manufacturing
Last approval date
2025-05-19
Recognitions
National High-Tech EnterpriseTechnology-based SMEGazelle enterpriseHidden champion

Business registration data from Tianyancha, as of 2026-09-03. 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

12017 · K170958

FDA listed device types

Clamp, Vascular 1Oral Wound Dressing 1Hemostatic Wound Dressing Without Thrombin Or Other Biologics 1Tape And Bandage, Adhesive 1Splint, Intranasal Septal 1

Registration details (sample)

MarketIdentifierNameClass / date
CN鲁械注准20252140791手术膜Class II
CN鲁械注准20242140432手术切口无菌保护膜Class II
CN鲁械注准20242140129一次性使用介入包Class II
CN鲁械注准20212140366医用防护口罩Class II
EU00870053000575OneStop Vascular 2"x2"Class III
EU00870053000537OneStop Vascular 1.5"x1.5"Class III
EU00870053000452GuardaCare PRO 4"x4", 8plyClass III
EU00870053000520GuardaCare PRO 4"x4", 8plyClass III
UK46922ChitoGauze XR PROClass III
USK170958ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cm2017-08-29
CA74932HEMCON CHITO-FLEX SURGICALClass II

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