HomeChinaAuckland Medical Polymer (Tianjin) Co., Ltd.

Auckland Medical Polymer (Tianjin) Co., Ltd.

China · Tianjin · www.okltj.com
✓ Record-verifiedregistrations found in 9 marketsEU SRN CN-MF-000033571Unified social credit code 911201117972552377

This company holds 25 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Saudi Arabia, Canada, Taiwan, Australia, Israel — 8 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
25China registrations
Class I 24Class II 1
as of 2026-09-04
EUEuropean UnionEUDAMED
5UDI-DI device records
Class I 5
USUnited StatesFDA openFDA
6listed device types
Class I 5Class II 1Class III 0
plus 6 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
5registered device records
Class I 5
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
1registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
2 including historic records
TWTaiwanTFDA
2valid device licences
Class I 2
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
9active ARTG entries
Class I 8IIb 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 Union5 raw hits, 0 excluded, 5 confirmed
United States6 registration records, 1 510(k), 0 PMA, 1 excluded
China25 certificates (Class III 0 / II 1 / I 24), as of 2026-09-04
United Kingdom5 confirmed, 1 excluded
Saudi Arabia1 confirmed, 0 excluded
Manufacturer names merged into this page: Auckland Medical Polymer (Tianjin) Co., Ltd · AUCKLAND MEDICAL POLYMER (TIANJIN) CO., LTD. · AUCKLAND MEDICAL POLYMER (TIANJIN) CO., LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000033571
EU authorised representative
SUNGO Europe B.V.
UK responsible person
KINGSMEAD SERVICE LIMITED
Unified social credit code
911201117972552377
Exhibition record
CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
City
Tianjin
Social-insurance enrolees
58
Annual revenue
RMB 30–50M
Website
www.okltj.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesMedical Devices & Clinical EquipmentSurgical systems & instruments

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
2007-01-23
Registered capital
CNY 3,192,000
Paid-in capital
CNY 3,192,000
Legal form
Limited liability company
Industry classification
Professional technical services
Last approval date
2026-08-17
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseGazelle 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

12020 · K183148

FDA listed device types

Electrosurgical, Cutting & Coagulation & Accessories 1Protector, Skin Pressure 1Accessory, Surgical Apparel 1Support, Patient Position 1Accessories, Traction 1Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) 1

Registration details (sample)

MarketIdentifierNameClass / date
CN津械注准20212010416负极板回路垫Class II
CN津械备20210502号神经外科基础手术器械包Class I
CN津械备20210499号外科基础手术器械包Class I
CN津械备20210492号眼科基础手术器械包Class I
EU06953497000210Class I
EU06953497000517Class I
EU06953497004911Class I
EU06953497003464Class I
UK42551Patient Return Electrode PadClass I
UK58878Positioning PadsClass I
UK58878Positioning PadsClass I
USK183148OKLand Patient Return Electrode Pad2020-02-04
SAME0000002980SFDAA02483Positioning Pads

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