SMARTDATA SUZHOU CO., LTD

FDA Device Registration & Listing · Suzhou Jiangsu, CN · Registration 3008058134

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3008058134
FEI Number
3008058134
Entity Name
SMARTDATA SUZHOU CO., LTD
City/State/Country
Suzhou Jiangsu, CN
Establishment Address
F4, Building 7, 198 Jinshan Rd, Suzhou Jiangsu 215011, CN
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Smartdata Suzhou Co., Ltd. (Owner Number: 10030656)
Owner / Operator Contact Address
F4, Building 7, 198 Jinshan Rd, Suzhou, CN-JS 215011, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

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Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OCX Endoscopic Irrigation/Suction System Gastroenterology, Urology Class 2 876.1500 2023-08-08
OCX Endoscopic Irrigation/Suction System Gastroenterology, Urology Class 2 876.1500 2019-04-17
FFY Adaptor, Bulbs, Miscellaneous, For Endoscope Gastroenterology, Urology Class 1 876.1500 2019-07-11
OCX Endoscopic Irrigation/Suction System Gastroenterology, Urology Class 2 876.1500 2019-11-03
OCX Endoscopic Irrigation/Suction System Gastroenterology, Urology Class 2 876.1500 2020-04-14
FCX Insufflator, Automatic Carbon-Dioxide For Endoscope Gastroenterology, Urology Class 2 876.1500 2020-04-14
OCX Endoscopic Irrigation/Suction System Gastroenterology, Urology Class 2 876.1500 2018-07-12
ODC Endoscope Channel Accessory Gastroenterology, Urology Class 2 876.1500 2018-07-12
OCX Endoscopic Irrigation/Suction System Gastroenterology, Urology Class 2 876.1500 2023-11-09
ODC Endoscope Channel Accessory Gastroenterology, Urology Class 2 876.1500 2023-11-09
CBC Bottle, Collection And Trap, Breathing System (Uncalibrated) General Hospital Class 2 880.6740 2026-01-21
HMP Pad, Eye General, Plastic Surgery Class 1 878.4440 2026-01-21
OCX Endoscopic Irrigation/Suction System Gastroenterology, Urology Class 2 876.1500 2019-06-09
ODC Endoscope Channel Accessory Gastroenterology, Urology Class 2 876.1500 2019-06-09
OCX Endoscopic Irrigation/Suction System Gastroenterology, Urology Class 2 876.1500 2020-05-18
MNL Accessories, Cleaning Brushes, For Endoscope Gastroenterology, Urology Class 1 876.1500 2026-01-21
ODC Endoscope Channel Accessory Gastroenterology, Urology Class 2 876.1500 2020-06-26
ODC Endoscope Channel Accessory Gastroenterology, Urology Class 2 876.1500 2023-07-10
OCX Endoscopic Irrigation/Suction System Gastroenterology, Urology Class 2 876.1500 2023-07-10
OCU Endoscopic Storage Cover Gastroenterology, Urology Class 2 876.1500 2021-05-26
ODC Endoscope Channel Accessory Gastroenterology, Urology Class 2 876.1500 2020-06-26
OCX Endoscopic Irrigation/Suction System Gastroenterology, Urology Class 2 876.1500 2023-02-03

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Smartdata Suzhou Co., Ltd.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0010-2023 Hobbs Medical, Inc. 2
Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 260cm Disposable For endoscopy procedures Ref: 2190
Z-0011-2023 Hobbs Medical, Inc. 2
Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 165cm Disposable For endoscopy procedures Ref: 2191

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008058134. Last updated year: 2026. Please use registration number 3008058134 when referencing this establishment in official correspondence.
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