HomeChinaZhuji Pengtian Medical Instrument Co., Ltd.

Zhuji Pengtian Medical Instrument Co., Ltd.

China · 绍兴 · www.pengtianmed.com
✓ Record-verifiedregistrations found in 9 marketsEU SRN CN-MF-000013084Unified social credit code 913306817498202388

This company holds 13 NMPA certificates in China and has registrations in European Union, United States, Brazil, Canada, South Korea, Australia, Israel, Russia — 8 overseas markets. EU UDI-DI records ≥300, the first 300 verified individually.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
13China registrations
Class II 10Class III 3
as of 2026-09-04
EUEuropean UnionEUDAMED
≥300UDI-DI device records
Class I 51Class IIa 249
large result set — only the first 300 records were verified, so the real figure is at least this
USUnited StatesFDA openFDA
10listed device types
Class I 6Class II 4Class III 0
plus 10 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
25registered devices
Class I 11Class II 14
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
1 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
3GMP quality-system certificates
Import 3
AUAustraliaTGA ARTG
1active ARTG entries
Class Is (sterile) 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
4registrations
RURussiaRoszdravnadzor
4active registrations
Class 2a 4
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 Union757 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified
United States10 registration records, 0 510(k), 0 PMA
China13 certificates (Class III 3 / II 10 / I 0), as of 2026-09-04
Brazil25 confirmed, 0 excluded
Manufacturer names merged into this page: Zhuji Pengtian Medical Instrument Co.,Ltd. · ZHUJI PENGTIAN MEDICAL INSTRUMENT CO., LTD. · ZHUJI PENGTIAN MEDICAL INSTRUMENT CO., LTD · Zhuji Pengtian Medical Instrument Co., Ltd

Regulatory identity

EU manufacturer SRN
CN-MF-000013084
EU authorised representative
Meditech X-Ray Spółka z o.o.
Unified social credit code
913306817498202388
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai)

Company information

Country
China
Social-insurance enrolees
88
Website
www.pengtianmed.com

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
2003-05-13
Registered capital
CNY 5,000,000
Paid-in capital
CNY 5,000,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Special-purpose equipment manufacturing
Last approval date
2026-08-14
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseInnovative SME
Listing
Regional equity 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 listed device types

showing 8 of 10
Forceps, Biopsy, Non-Electric 1Accessories, Cleaning Brushes, For Endoscope 1Endoscopic Bite Block 1Scissors, General, Surgical 1Hysteroscope Accessories 1Forceps, Biopsy, Gynecological 1Ligator, Esophageal 1Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt 1

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20213140170一次性内镜用注射针Class III
CN国械注准20213010181一次性使用热活检钳Class III
CN国械注准20163011453一次性使用电圈套器Class III
CN浙械注准20252021482夹子装置Class II
EU06950190420321Class I
EU06950190420314Class I
EU06950190420239Class I
EU06950190420222Class I
BR81594029009Cateter Extração de Cálculo tipo Basket Descartável ARGUSClass II
BR81594029010Cateter Extração de Cálculo tipo Basket ARGUSClass II
BR81594029011ESCOVA PARA CITOLOGIA ARGUSClass II

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