Conod Medical Co., Limited
Registered establishment in Changshu, Jiangsu, China. 48 device types, 2 clearances.
Conod Medical Co., Limited is a contract manufacturer holding a current FDA establishment registration. The registration covers Forceps, Enema Kit and 46 other device types. Its earliest product listing with the FDA dates from 2007.
48device types registered with the FDA
2510(k) clearances
Registration
| Registered name | Conod Medical Co.,Limited |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3006673317 |
| FEI number | 3005596530 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 江苏康诺医疗器械股份有限公司 |
|---|---|
| Unified social credit code | 91320581754611596D |
| Source | NMPA UDI database |
Location
| City | Changshu |
|---|---|
| Province | Jiangsu |
| Address | No.11 Hongfeng Road Baimao Industrial Park;No.2 Zengfu Road Baimao Industrial Park |
| Postal code | 215532 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessories, Catheter | Class 1 | (Confidential)Waste collection bag, Waste collection bag | 2011 | 33 |
| Accessory, Surgical Apparel | Class 1 | Face Mask | 2020 | 439 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | Class 1 | Apparatus, Suction, Single Patient USE, Portable, Nonpowered | 2007 | 58 |
| Bag, Urine Collection, Leg, For External Use, Non-Sterile | Class 1 | 2023 | 47 | |
| Bag, Urine Collection, Leg, For External Use, Sterile | Class 1 | 2007 | 52 | |
| Bath, Sitz, Nonpowered | Class 1 | Sitz BAG, Enema SET | 2011 | 22 |
| Brush, Cleaning, Tracheal Tube | Class 1 | Brush, Cleaning, Tracheal Tube | 2018 | 26 |
| Catheter And Tip, Suction | Class 2 | Suct instr yank blb w vent; Suct instr yank blb w/o vent; Suct instr yank reg w vent; Suct instr yank reg w/o vent, ST, Suct instr yank blb w/o vent, Suct instr yank reg w/o vent, Suct instr yank reg w vent, Suct instr yank blb w vent, Suct instr yank flx w vent and 6 more | 2007 | 70 |
| Catheter Care Tray | Class 2 | Catheter Care Tray | 2014 | 12 |
| Catheter, Irrigation | Class 1 | 2016 | 24 | |
| Catheter, Straight | Class 2 | (Confidential)PVC urethral catheter | 2012 | 21 |
| Chamber, Slide Culture | Class 1 | 2011 | 6 | |
| Collector, Urine, (And Accessories) For Indwelling Catheter | Class 2 | BAG, URINARY LEG W/STRAPS, LEG BAG; Collector, Urine (And Accessories) For Indwelling catheter, Urinary drainageBag hold, Drainage BAG, Urinary drainage bag 2000cc anti reflux chamber, Urinary drainage bag 2000cc, BAG, Urinary Drain, Vinyl LF Anit-Reflux W/Flutter Valve 2000 ML, Drain bag holder vinyl and 2 more | 2007 | 51 |
| Connector, Catheter | Class 1 | (confidential)5-IN-1 Connector | 2008 | 15 |
| Container, Specimen, Non-Sterile | Class 1 | 4 oz. Specimen Container w/Lid Non-Sterile; 800ml Urine/Stool specimen Collection, 4 oz. Specimen Container w/Lid Non-Sterile, Specimen Container, Speicmen Collector (Hat) Urine/Stool, Wht, Non-Str, Specimen Container, 4oz./120ccTransparent with Imprinted Opaque, Screw on Lid, Non-Str Leak Resistant | 2007 | 115 |
| Container, Specimen, Sterile | Class 1 | Specimen Container, 4oz./120ccTransparent w/imprinted Opaque, Screw on Lid, Tamper Evident Seal, Leak Resistant, Str, Specimen container, STR, Container, Specimen, Sterile, Specimen container | 2007 | 79 |
| Cuff, Tracheal Tube, Inflatable | Class 2 | 2021 | 6 | |
| Device, Incontinence, Urosheath Type, Non-Sterile | Class 1 | 2023 | 13 | |
| Device, Occlusion, Umbilical | Class 1 | 2012 | 18 | |
| Device, Paste-On For Incontinence, Non-Sterile | Class 1 | Multiple Models AND Brands, ( confidential) Urine collector pediatric 200ml clean | 2008 | 13 |
| Device, Paste-On For Incontinence, Sterile | Class 1 | Urine Collector Sterile, Latex Free, Urine collector pediatric st, Sterile or NON-sterileUrine collector pediatric | 2008 | 12 |
| Device, Urine Flow Rate Measuring, Non-Electrical, Disposable | Class 2 | Urinemeters, device, urine flow rate measuring, non-electrical, disposable – Urinemeters | 2007 | 19 |
| Enema Kit | Class 1 | Enema BAG W/Soap & Underpd 50/CS GSS, Enema Bag Set w/soaps, Enema SET, Enema Bucket 1500ML W/Soap, Enema Bag Set w/soaps; ENEMA BUCKET 1500ML W/SOAP; ENEMA SET | 2009 | 24 |
| Enteral Specific Transition Connectors | Class 2 | Medline ENFit Connectors | 2015 | 4 |
| Evacuator, Gastro-Urology | Class 2 | (Confidential)enema bag | 2009 | 5 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | Class N | Face mask, Protective face mask, Face mask with ear-loop, Face Mask | 2020 | 182 |
| Filter, Bacterial, Breathing-Circuit | Class 2 | 301435 BAC/VIR Depth Filter | 2011 | 15 |
| Forceps | Class 1 | Adson forcep | 2018 | 99 |
| Gastrointestinal Tubes With Enteral Specific Connectors | Class 2 | 2015 | 17 | |
| General Surgery Tray | Class 2 | Tracheostomy Care Kit | 2008 | 24 |
| Holder, Ureteral Catheter | Class 1 | Foley Catheter Holder, CONOD, Foley Catheter Holder | 2012 | 29 |
| I.V. Start Kit | Class 2 | 2016 | 7 | |
| Kit, Surgical Instrument, Disposable | Class 1 | Convinient Kit; SHAVE PREP KIT; Skin Staple removal Kit; Suture Removal tray; Tracheostomy Care Trays; Irrigation tray, Tracheostomy Care Kit, IV Start Kit, Dressing Change Tray, Central Line Dressing change kit, Suture Removal tray and 5 more | 2007 | 67 |
| Lubricant, Patient | Class 1 | lubrication gel (pre-filled syringe), (Confidential)lubrication gel (pre-filled syringe) | 2011 | 33 |
| Non-Surgical Gown | Class 1 | Isolation Gown; Medical Protection Clothing; Overall Isolation Gown | 2020 | 318 |
| Protector, Skin Pressure | Class 1 | 2016 | 101 | |
| Skin Prep Tray | Class 1 | 2019 | 8 | |
| Speculum, Vaginal, Nonmetal | Class 2 | Vaginal speclum | 2009 | 40 |
| Spirometer, Diagnostic | Class 2 | 301-436,313-7043 Pulmonapy Function Filter | 2011 | 10 |
| Suture Removal Kit | Class 1 | 2016 | 12 | |
| Syringe, Irrigating (Non Dental) | Class 1 | Flat top piston irrigation syringe 60cc ST, Enteral irrigation syringe 60cc NS, Bulb irrigation syringe 60cc ST, Piston enteral irrigation syringe 60cc NS, Thumb control piston irrigation syringe 60cc ST, EAR Bulb Syringe and 2 more | 2007 | 110 |
| System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile | Class 1 | Speci-Cath kit | 2014 | 23 |
| Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | Class 2 | 2008 | 11 | |
| Tray, Surgical, Instrument | Class 1 | (Confidential)Suture removal Tray | 2007 | 105 |
| Tube, Aspirating, Flexible, Connecting | Class 2 | Tube, Aspirating, Flexible, Connecting, Suction Tubing 3/16, Suction conneting tube, Suction Tubing 1/4, Suction connecting tube; ASPIRATING, FLEXIBLE, CONNECTING | 2007 | 51 |
| Tubes, Gastrointestinal (And Accessories) | Class 2 | Enteral Delivery SET | 2010 | 25 |
| Urinary Drainage Collection Kit, For Indwelling Catheter | Class 2 | 2016 | 11 | |
| Urine Collection Kit (Excludes Hiv Testing) | Class 1 | Midstream kit | 2020 | 7 |
Clearances
2 clearances name Conod Medical Co., Limited as applicant. 1 is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K203591 | 2021-07-02 | FXX | Traditional | This company |
| K181276 | 2018-07-12 | PIF | Traditional | This company |
| K082863 | 2009-01-09 | KNT | Traditional | Dynarex Corp. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2003 |
|---|---|
| Main products | Urology consumables, Catheters, Protective clothing, Masks |
| Certifications | TUV 13485, ISO 9001, ISO 40001, State Food and Drug Administration double white list |
| Export markets | 50+ countries (USA, European Union, Japan) |
| OEM and ODM | Offered |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.