Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006536657

FEI Number

3006536657

Entity Name

SUZHOU JINGLE POLYMER MEDICAL APPARATUS CO., LTD.

City/State/Country

SUZHOU Jiangsu, CN

Establishment Address

No. 215 LIANGANG RD., NEW DISTRICT, Suzhou High-tech Zone, SUZHOU Jiangsu 215129, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

SUZHOU JINGLE POLYMER MEDICAL APPARATUS (Owner Number: 9098739)

Owner / Operator Contact Address

No. 215 LIANGANG RD, NEW DISTRICT, Suzhou, CN-JS 215129, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Medline Suction Tubing Analyzer, gas, carbon-dioxide, gaseous-phase

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEC	Brush, Scrub, Operating-Room	General, Plastic Surgery	Class 1	878.4800	2015-09-01
OHR	Catheter Care Tray	Gastroenterology, Urology	Class 2	876.5130	2018-10-26
NKC	Tubing/Tubing With Filter, Insufflation, Laparoscopic	Obstetrics/Gynecology	Class 1	884.1730	2018-04-06
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2015-08-18
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-02-14
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2019-04-04
DRI	Monitor, Line Isolation	Cardiovascular	Class 1	870.2620	2017-08-30
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2013-01-25
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2007-03-07
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2014-04-10
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2009-06-22
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2016-04-25
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2015-07-14

Official Correspondent

Grace Wang

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

SUZHOU JINGLE POLYMER MEDICAL APPARATUS

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K102092	Prestige Ameritech	PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES	2010-10-06
K910471	Baxter Healthcare Corp	MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE	1991-03-08
K142467	Abeon Medical Corporation	IntelAir Nasal Airway Support System	2014-11-24
K861213	Datex Division Instrumentarium Corp.	PB 254 IR - SPECTROMETER	1986-04-04
K172904	Philips Medizin Systeme Boeblingen GmbH	IntelliVue Capnography Extension, IntelliVue Microstream Extension	2017-12-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0021-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N, Part Number CS08651-01
Z-0024-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657
Z-0025-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-02
Z-0026-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER, Part Number CS08657-01
Z-0027-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006536657. Last updated year: 2026. Please use registration number 3006536657 when referencing this establishment in official correspondence.