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Scivita Medical

✓ Record-verifiedregistrations found in 9 marketsEU SRN CN-MF-000010305Unified social credit code 91320594MA1MXU2G4A

This company holds 5 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Taiwan, Singapore, Hong Kong, Israel — 8 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

5China registrations

Class II 5

as of 2026-09-04

EUEuropean UnionEUDAMED

275UDI-DI device records

Class I 42Class IIa 233

USUnited StatesFDA openFDA

19listed device types

Class I 3Class II 16Class III 0

plus 17 registration records and 13 510(k)

UKUnited KingdomMHRA PARD

13registered device records

Class I 2Class IIa 11

BRBrazilANVISA

17registered devices

Class II 17

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

5valid device licences

Class II 5

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

3registrations

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 Union275 raw hits, 0 excluded, 275 confirmed

United States17 registration records, 13 510(k), 0 PMA

China5 certificates (Class III 0 / II 5 / I 0), as of 2026-09-04

United Kingdom13 confirmed, 0 excluded

Brazil17 confirmed, 0 excluded

Manufacturer names merged into this page: SCIVITA MEDICAL TECHNOLOGY CO., LTD.

Regulatory identity

EU manufacturer SRN: CN-MF-000010305
EU authorised representative: Shanghai International Holding Corp. GmbH(Europe)
UK responsible person: Etheria Medical Ltd
Unified social credit code: 91320594MA1MXU2G4A
Exhibition record: CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Business registration

Registration status: Active
Incorporated: 2016-10-28
Registered capital: CNY 373,831,919
Paid-in capital: CNY 373,831,919
Legal form: Limited liability company (foreign-invested, not wholly owned)
Industry classification: Special-purpose equipment manufacturing
Last approval date: 2026-08-25
Recognitions: Micro and small enterpriseNational High-Tech EnterpriseTechnology-based SMESRDI SMEGazelle enterpriseAbove-designated-size industrial enterprise

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

12019

12020

22021

32023

22024

22025

22026

FDA listed device types

showing 8 of 19

Forceps, Biopsy, Non-Electric 1Forceps, Biopsy, Gynecological 1Container, Specimen, Sterile 1Dislodger, Stone, Basket, Ureteral, Metal 1Nasopharyngoscope (Flexible Or Rigid) 1Cystoscope And Accessories, Flexible/Rigid 1Bronchoscope (Flexible Or Rigid) 1Arthroscope 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	苏械注准20222060692	一次性使用电子胆道成像导管	Class II
CN	苏械注准20212061722	一次性使用电子支气管成像导管	Class II
CN	苏械注准20212061706	一次性使用电子支气管内窥镜	Class II
CN	苏械注准20212061394	医用内窥镜LED冷光源	Class II
EU	06971381256963	Single-use Video Cholangioscope	Class IIa
EU	06971381258882	Single-use Video Cholangioscope	Class IIa
EU	06971381259629	Endoscopic Image Processor	Class I
EU	06971381258851	Single-use Grasping Forceps	Class IIa
UK	46452	Single-use Extraction Baskets	Class IIa
UK	18034	Endoscopic Image Processor	Class I
UK	38711	Single-use Biopsy Forceps	Class IIa
US	K262552	Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)	2026-08-14
US	K251338	Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G; Full HD Visualization Endoscopic Image Processor: HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D)	2026-01-20
US	K243708	Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.)	2025-03-27
BR	80082919061	LAPAROSCÓPIO 4K UHD - SCIVITA	Class II
BR	10341359022	Videoscópio Descartável para Colangioscopia	Class II
BR	10341359023	Processador de Imagens Endoscópicas de Visualização Full HD	Class II

Scivita Medical

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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