HomeChinaAllgens Medical Technology Co., Ltd.

Allgens Medical Technology Co., Ltd.

China · 北京 · www.allgensmed.cn
✓ Record-verifiedregistrations found in 2 marketsUnified social credit code 91110108769900489W

This company holds 4 NMPA certificates in China and has registrations in United States — 1 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
4China registrations
Class III 4
as of 2026-09-04
EUEuropean UnionEUDAMED
0UDI-DI device records
USUnited StatesFDA openFDA
1listed device types
Class I 0Class II 1Class III 0
plus 1 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
0registered device records
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
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.

United States1 registration records, 1 510(k), 0 PMA
China4 certificates (Class III 4 / II 0 / I 0), as of 2026-09-04
Manufacturer names merged into this page: Allgens Medical Technology Co.,Ltd.

Regulatory identity

Unified social credit code
91110108769900489W
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
128
Annual revenue
RMB 100–500M
Website
www.allgensmed.cn
Product categories
植入器械

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
2004-12-22
Registered capital
CNY 137,008,584
Paid-in capital
CNY 137,008,584
Legal form
Joint-stock limited company (Sino-foreign joint venture, listed)
Industry classification
Special-purpose equipment manufacturing
Last approval date
2025-12-12
Recognitions
National High-Tech EnterpriseGazelle enterpriseRecognised enterprise technology centreAbove-designated-size industrial enterprise
Listing
Listed on the STAR Market

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

12015 · K141725

FDA listed device types

Filler, Bone Void, Calcium Compound 1

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20253131942可吸收复合骨修复材料Class III
CN国械注准20193171523人工骨修复材料Class III
CN国械注准20193131531人工骨修复材料Class III
CN国械注准20143132075人工骨修复材料Class III
USK141725BONGOLD BONE GRAFT MATERIAL2015-07-09

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