HomeChinaNANJING POLYMER MEDICAL TECHNOLOGY CO.,LTD

NANJING POLYMER MEDICAL TECHNOLOGY CO.,LTD

China · 南京 · www.njpolymer.cn
✓ Record-verifiedregistrations found in 2 marketsUnified social credit code 91320191MA1MGN3E2Y

This company holds 28 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
28China registrations
Class I 2Class II 10Class III 16
as of 2026-09-04
EUEuropean UnionEUDAMED
0UDI-DI device records
USUnited StatesFDA openFDA
28510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 28 510(k), 97 PMA
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.

European Union4,967 raw hits, 300 excluded, 0 confirmed. Large result set — only the first 300 verified
United States0 registration records, 28 510(k), 97 PMA, 43 excluded
China28 certificates (Class III 16 / II 10 / I 2), as of 2026-09-04
United Kingdom0 confirmed, 8 excluded
Brazil0 confirmed, 10 excluded
Saudi Arabia0 confirmed, 2 excluded
Canada0 confirmed, 3 excluded

Regulatory identity

Unified social credit code
91320191MA1MGN3E2Y
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
225
Annual revenue
RMB 50–100M
Website
www.njpolymer.cn
Product categories
手术室及急救

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
2016-03-23
Registered capital
CNY 60,000,000
Paid-in capital
CNY 60,000,000
Legal form
Joint-stock limited company (foreign-invested)
Industry classification
Professional technical services
Last approval date
2026-04-30
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseTechnology-based SMEPrivate technology enterpriseSRDI 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

51983
21984
11985
11989
21991
41992
21994
11995
21997
21998
32000
32001

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20263170986口腔用骨填充材料Class III
CN国械注准20263170976口腔修复膜Class III
CN国械注准20263021129带垫片聚酯非吸收缝合线Class III
CN国械注准20253172335聚醚醚酮颌面部植入物Class III
USK011945RIGID GAS PERMEABLE CONTACT LENS SOLUTION2001-09-12
USK003932BOSTON EO (ENFLUFOCON B) CONTACT LENS FOR ORTHOKERATOLGY2001-02-16
USK003933BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGY2001-02-16

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