HomeChinaBioRegen Biomedical (Changzhou) Co. Ltd.

BioRegen Biomedical (Changzhou) Co. Ltd.

China · Changzhou · www.bioregenmed.com
✓ Record-verifiedregistrations found in 9 marketsEU SRN CN-MF-000007975Unified social credit code 91320412675465930M

This company holds 9 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Canada, Taiwan, Singapore, Australia, Israel — 8 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
9China registrations
Class II 6Class III 3
as of 2026-09-04
EUEuropean UnionEUDAMED
9UDI-DI device records
Class IIa 4Class III 5
USUnited StatesFDA openFDA
2listed device types
Class I 2Class II 0Class III 0
plus 2 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
2registered device records
Class IIa 1Class 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
3 including historic records
TWTaiwanTFDA
3valid device licences
Class I 2Class III 1
SGSingaporeHSA SMDR
3device registrations
CLASS B 1CLASS D 2
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
3active ARTG entries
Class III 2IIa 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
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 Union9 raw hits, 0 excluded, 9 confirmed
United States2 registration records, 0 510(k), 0 PMA
China9 certificates (Class III 3 / II 6 / I 0), as of 2026-09-04
United Kingdom2 confirmed, 0 excluded
Canada1 confirmed, 0 excluded
Manufacturer names merged into this page: BIOREGEN BIOMEDICAL (CHANGZHOU) CO., LTD · BIOREGEN BIOMEDICAL (CHANGZHOU) CO. LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000007975
EU authorised representative
Shanghai International Holding Corp. GmbH(Europe)
UK responsible person
Etheria Medical Ltd
Unified social credit code
91320412675465930M
Exhibition record
CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai)

Company information

Country
China
City
Changzhou
Social-insurance enrolees
181
Annual revenue
RMB 50–100M
Website
www.bioregenmed.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesMedical Devices & Clinical EquipmentENT & audiology

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
2008-04-28
Registered capital
CNY 60,000,000
Paid-in capital
CNY 59,694,782
Legal form
Joint-stock limited company (unlisted)
Industry classification
Pharmaceutical manufacturing
Last approval date
2026-08-04
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseTechnology-based SMEPrivate technology enterpriseGazelle enterpriseAbove-designated-size industrial enterprise
Listing
Listed on the NEEQ

Business registration data from Tianyancha, as of 2026-09-01. 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 listed device types

Dressing, Wound, Hydrogel Without Drug And/Or Biologic 1Splint, Intranasal Septal 1

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20223140092交联透明质酸钠凝胶Class III
CN国械注准20173141030医用交联透明质酸钠凝胶Class III
CN国械注准20153141542宫腔用交联透明质酸钠凝胶Class III
CN苏械注准20252140209透明质酸钠创面凝胶Class II
EU06952181200219MateRegen GelClass III
EU06952181200196HyaRegen GelClass III
EU06952181200233MateRegen GelClass III
EU06952181200226MateRegen GelClass III
UK47764Nasal and Sinus Dressing PureRegen Gel SinusClass IIa
UK47764Absorbable Adhesion Barrier Gel HyaRegen Gel/ MateRegen GelClass III
CA96000NASAL/SINUS AND OTOLOGIC DRESSINGClass II

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