Hangzhou Rollmed Co., Ltd.
Manufacturer and brand owner in Hangzhou, Zhejiang, China. 127 device types, 1 product catalogued.
Hangzhou Rollmed Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Urinal, Pad, Eye and 125 other device types. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2016.
127device types registered with the FDA
1product
Registration
| Registered name | HANGZHOU ROLLMED CO.,LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3013530901 |
| FEI number | 3013530901 |
| DUNS | 542984571 |
| Establishment type | Contract manufacturer, Contract steriliser, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 杭州乐宇医疗器械有限公司 |
|---|---|
| Source | customs registration record |
Location
| City | Hangzhou |
|---|---|
| Province | Zhejiang |
| Address | Room 913, Yuanmao Mansion No.5, |
| Postal code | 310012 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessories, Wheelchair | Class 1 | Wheelchair | 2017 | 80 |
| Adaptor, Ureteral Catheter | Class 1 | Adaptor, Ureteral Catheter, Wrological catheter and accessories | 2024 | 5 |
| Airway, Oropharyngeal, Anesthesiology | Class 1 | Oropharyngeal Airway | 2018 | 84 |
| Albumin, Fitc, Antigen, Antiserum, Control | Class 2 | FIT test cassette(stool occulit blood) | 2020 | 2 |
| Antigens, Cf (Including Cf Control), Influenza Virus A, B, C | Class 1 | Antigens, Cf (Including Cf Control), Influenza Virus A, B, C | 2020 | 1 |
| Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4 | Class 1 | Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4 | 2020 | 2 |
| Antigens, Ha (Including Ha Control), Influenza Virus A, B, C | Class 1 | Antigens, Ha (Including Ha Control), Influenza Virus A, B, C | 2020 | 1 |
| Antigens, Ha (Including Ha Control), Parainfluenza Virus 1-4 | Class 1 | Influenza A&B | 2020 | 1 |
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | Class 2 | suction liner | 2023 | 30 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | Class 1 | suction liner | 2023 | 58 |
| Appliance, Colostomy, Disposable | Class 1 | Colostomybag,Appliance, Colostomy, Disposabe | 2024 | 8 |
| Applicator, Absorbent Tipped, Non-Sterile | Class 1 | Cotton Swab, swab applicator, specimen collection Foam swab, Specimen collection polyester swab, Cervical specimen collection Flocked swab, Nasopharyngeal Flocked swab, Oropharyngeal Flocked swab DNA flocked swab, sterile Sponge Swab and 3 more | 2017 | 186 |
| Applicator, Absorbent Tipped, Sterile | Class 1 | swab applicator, Applicator, Absorbent Tipped, Sterile | 2017 | 100 |
| Armboard, Wheelchair | Class 1 | Wheelchair | 2017 | 14 |
| Attachment, Commode, Wheelchair | Class 1 | Wheelchair | 2017 | 70 |
| Attachment, Narrowing, Wheelchair | Class 1 | Wheelchair | 2017 | 5 |
| Bag, Drainage, With Adhesive, Ostomy | Class 1 | BAG, Drainage, With Adhesive, Ostommy, colostomy bag | 2023 | 49 |
| Bag, Stomal | Class 1 | colostomy bag | 2023 | 7 |
| Bag, Urinary, Ileostomy | Class 1 | colostomy bag | 2023 | 4 |
| Bag, Urine Collecting, Ureterostomy | Class 1 | colostomy bag | 2023 | 27 |
| Bag, Urine Collection, Leg, For External Use, Non-Sterile | Class 1 | BAG, Urine Collection, LEG, FOR External USE, NON-Sterile | 2024 | 47 |
| Bag, Urine Collection, Leg, For External Use, Sterile | Class 1 | Rollmed | 2016 | 52 |
| Bandage, Cast | Class 1 | bandage | 2017 | 81 |
| Bandage, Elastic | Class 1 | bandage | 2017 | 280 |
| Bedding, Disposable, Medical | Class 1 | Underpad | 2021 | 308 |
| Belt, Wheelchair | Class 1 | 2017 | 24 | |
| Board, Lap, Wheelchair | Class 1 | Wheelchair | 2017 | 14 |
| Bottle, Blow | Class 1 | Reagent Bottle | 2018 | 3 |
| Bottle, Collection, Vacuum | Class 2 | suction liner | 2023 | 88 |
| Brake, Extension, Wheelchair | Class 1 | Wheelchair | 2017 | 19 |
| Brush, Cleaning, Tracheal Tube | Class 1 | Rollmed | 2016 | 26 |
| Cane, Safety Walk | Class 1 | Wheelchair | 2017 | 25 |
| Cap, Surgical | Class 1 | Rollmed | 2016 | 178 |
| Cement, Stomal Appliance, Ostomy | Class 1 | CEMENT, STOMAL APPLIANCE, OSTOMY, Ostomy Cream, SkinBarrier Strip, Ostomy Fastened Ring | 2024 | 7 |
| Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | Class 1 | centrifuge/centrifuge tube | 2017 | 37 |
| Climber, Curb, Wheelchair | Class 1 | Wheelchair | 2017 | 13 |
| Closure, Wound, Adhesive | Class 1 | Wound plaster | 2017 | 22 |
| Collector, Ostomy | Class 1 | Collector, Ostomy | 2024 | 18 |
| Container, Embedding | Class 1 | urine container/stool container/Embedding cassettes | 2017 | 8 |
| Container, Liquid Medication, Graduated | Class 1 | Medcine cup | 2017 | 68 |
| Container, Specimen Mailer And Storage, Non-Sterile | Class 1 | Cardboard slides mailers/sildes mailers | 2017 | 51 |
| Container, Specimen Mailer And Storage, Sterile | Class 1 | Bouin’s-Collect FIuid,VTM-N Collection and Transport Kit, VTM Collection and Transport Kit ,Container, Specimen mailer and storage, sterile | 2020 | 33 |
| Container, Specimen, Sterile | Class 1 | saliva collection kit, 24Hours horizontal Urinal 3000cc, Urine sediment tube | 2020 | 79 |
| Cotton, Roll | Class 1 | Rollmed | 2016 | 107 |
| Cover, Shoe, Operating-Room | Class 1 | Rollmed, shoe cover | 2016 | 176 |
| Coverslips, Microscope Slide | Class 1 | Microscope slides/Microscope Cover glass | 2017 | 32 |
| Crusher, Spur, Colostomy | Class 1 | Colostomybag, Crusher, Spur, Colostomy | 2024 | 1 |
| Cushion, Wheelchair | Class 1 | Wheelchair | 2017 | 53 |
| Cylinder, Compressed Gas, And Valve | Class 1 | Cylinder | 2018 | 9 |
| Depressor, Metal Tongue, Surgical | Class 1 | wooden tongue depressors | 2016 | 10 |
| Depressor, Tongue, Non-Surgical | Class 1 | Tongue Depressor | 2025 | 100 |
| Device, Anti-Tip, Wheelchair | Class 1 | Wheelchair | 2017 | 22 |
| Device, Incontinence, Urosheath Type, Non-Sterile | Class 1 | urine catheter | 2025 | 13 |
| Dish, Tissue Culture | Class 1 | petri dish | 2017 | 30 |
| Dress, Surgical | Class 1 | Rollmed | 2016 | 71 |
| Dressing, Compression | Class 1 | bandage | 2017 | 87 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | Class 1 | Burn Care | 2025 | 118 |
| Driver, Surgical, Pin | Class 1 | Safety Pins | 2025 | 12 |
| Elastomer, Silicone, For Scar Management | Class 1 | silicone scar sheet | 2023 | 85 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Class 1 | Cryo tube, Cell Spreader, Loops, PCR Tube, PCR Plate | 2019 | 72 |
| Exerciser, Non-Measuring | Class 1 | Breathing Trainer | 2022 | 82 |
| First Aid Kit Without Drug | Class 1 | first aid bag | 2025 | 132 |
| Flask, Tissue Culture | Class 1 | Flask, Beaker, Cell Culture Flask; Cell Culture Plate; Deep Well Plate; Dish; Elisa Plate; Pcr Plate; Storage Bottle | 2018 | 9 |
| Floss, Dental | Class 1 | dental floss pick, C | 2025 | 151 |
| Footrest, Wheelchair | Class 1 | Wheelchair | 2017 | 25 |
| Gauze / Sponge,Nonresorbable For External Use | Class 1 | Rollmed | 2016 | 266 |
| Gauze/Sponge, Internal, X-Ray Detectable | Class 1 | Rollmed | 2016 | 67 |
| Handrim, Wheelchair | Class 1 | Wheelchair | 2017 | 12 |
| Hill Holder, Wheelchair | Class 1 | Wheelchair | 2017 | 9 |
| Holder, Crutch And Cane, Wheelchair | Class 1 | Wheelchair | 2017 | 22 |
| Holder, Ear Speculum | Class 1 | Vaginal Speculum | 2024 | 2 |
| Instrument, Manual, Surgical, General Use | Class 1 | Centrifuge Tube; Cryopreservation Tube; Microcentrifuge Tube, Pasteur Pipette; Pcr Tube; Pipette Tips; Sample Vials; Syringe Filter, Pipette Tips, Microcentrifuge Tube, Centrifuge Tube, Cryopreservation Tube and 4 more | 2020 | 110 |
| Kit, First Aid, Talking | Class 1 | Rollmed | 2016 | 18 |
| Kit, Surgical Instrument, Disposable | Class 1 | Metal Tweezer | 2025 | 67 |
| Laceration Tray | Class 1 | Sterile Gauze Pad 3*3“/12 PLY, Sterile Gauze Pad 2*2“/8 PLY, Sterile Gauze Pad 4*4“/12 PLY | 2025 | 1 |
| Mask, Gas, Anesthetic | Class 1 | Anaesthesia Mask | 2018 | 71 |
| Mask, Oxygen | Class 1 | Rollmed | 2016 | 126 |
| Mask, Oxygen, Non-Rebreathing | Class 1 | Nonrebreathing mask | 2018 | 72 |
| Mask, Scavenging | Class 1 | Mask, Face Mask, Nonwoven Face Mask, Disposable Medical face Mask,Daily protective mask, N95 protective mask, N95 Protective Mask, Face Mask, Nonwoven Face Mask, Daily Protective Mask, Disposable Medical Face Mask and 1 more | 2020 | 158 |
| Micro Pipette | Class 1 | pipette tips, transfer pipette | 2017 | 29 |
| Mixer, Blood Tube | Class 1 | singel-use container for human venous blood specimen collection | 2017 | 8 |
| Mouthpiece, Saliva Ejector | Class 1 | saliva ejector | 2017 | 68 |
| Non-Surgical Gown | Class 1 | Rollmed | 2016 | 318 |
| Pack, Hot Or Cold, Disposable | Class 1 | Fever Cooling Patch | 2025 | 176 |
| Pad, Eye | Class 1 | eyp pad, EYE PAD, Adult, EYE PAD, Child | 2017 | 100 |
| Permanently Mounted Wheelchair Platform Lift | Class 2 | Wheelchair | 2017 | 2 |
| Pipette, Pasteur | Class 1 | pasteur pipettes, Pipette Tips With/Without Filter, Free Of Rnase, Dnase, Dna, Low Retention | 2017 | 20 |
| Pouch, Colostomy | Class 1 | Colostomybag, Pouch, Colostomy | 2024 | 25 |
| Protector, Ostomy | Class 1 | Protector, Ostomy | 2024 | 33 |
| Reagent, Coronavirus Serological | Class N | COVID-19(SARS-CoV-2)Ig M Antibody Test Kit(Colloidal Gold), COVID-19(SARS-CoV-2)IgM/IgG Antibody Test Kit(Colloidal Gold), COVID- 19(SARS-CoV-2)IgG Antibody Test Kit(Colloid al Gold) | 2020 | 12 |
| Restraint, Wheelchair, Non-Protective | Class 1 | Wheelchair | 2017 | 15 |
| Rod, Colostomy | Class 2 | Colostomy bag, Rod, Colostomy | 2024 | 1 |
| Scale, Patient | Class 1 | Baby scale | 2017 | 25 |
| Scale, Platform, Wheelchair | Class 1 | scale | 2017 | 10 |
| Scale, Stand-On, Patient | Class 1 | Scale | 2018 | 27 |
| Scaler, Periodontic | Class 1 | scale | 2017 | 34 |
| Scissors, General, Surgical | Class 1 | Rollmed | 2016 | 83 |
| Shaker/Stirrer | Class 1 | ptfe megnetic stir bar | 2017 | 13 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | Class 1 | Goggles | 2020 | 384 |
| Silicone Hydrogel For Scar Management | Class 1 | silicone scar sheet | 2023 | 22 |
| Sling, Arm | Class 1 | Triangular Bandage | 2025 | 126 |
| Sling, Overhead Suspension, Wheelchair | Class 1 | Wheelchair | 2017 | 5 |
| Specula Accessories | Class 1 | Vaginal Speculum | 2024 | 3 |
| Speculum, Ent | Class 1 | Vaginal Speculum | 2024 | 9 |
| Speculum, Illuminated | Class 1 | Vaginal Speculum | 2024 | 3 |
| Speculum, Non-Illuminated | Class 1 | Vaginal Speculum | 2024 | 3 |
| Speculum, Rectal | Class 1 | Vaginal Speculum | 2024 | 8 |
| Speculum, Vaginal, Metal | Class 1 | Vaginal Speculum | 2024 | 8 |
| Speculum, Vaginal, Metal, Fiberoptic | Class 1 | Vaginal Speculum | 2024 | 2 |
| Speculum, Vaginal, Nonmetal | Class 2 | Vaginal speculum | 2018 | 40 |
| Speculum, Vaginal, Nonmetal, Fiberoptic | Class 2 | Vaginal Speculum | 2024 | 1 |
| Stethoscope Head | Class 1 | stethoscope | 2017 | 6 |
| Stethoscope, Fetal | Class 1 | stethoscope | 2018 | 4 |
| Stethoscope, Manual | Class 1 | Stethoscope | 2018 | 64 |
| Strip, Polishing Agent | Class 1 | Strip CAP | 2021 | 18 |
| Support, Head And Trunk, Wheelchair | Class 1 | Wheelchair | 2017 | 10 |
| System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile | Class 1 | Rollmed | 2016 | 13 |
| Tape And Bandage, Adhesive | Class 1 | JUNIOR Adhesive, M, Knee/Elbow adhesive Plaster,80*100MM latex free, Knee/Elbow adhesive Plaster,60*100MM, Adhesive Plaster, S, Adhesive Plaster, M,Latex, First Tape Roll and 20 more | 2017 | 353 |
| Test, Methamphetamine, Employment And Insurance Testing, Exempt | Class 2 | MET | 2020 | 13 |
| Tips And Pads, Cane, Crutch And Walker | Class 1 | Wheelchair | 2017 | 69 |
| Tourniquet Kit | Class 1 | TPE tournquiet | 2025 | 2 |
| Tourniquet, Gastro-Urology | Class 1 | Tourniquet | 2018 | 1 |
| Tray, Surgical, Instrument | Class 1 | Centrifuge Tube Rack, Test Tube Rack, Staining Jar and Racks | 2019 | 105 |
| Tube, Collection, Capillary Blood | Class 1 | vacuum blood tube | 2017 | 16 |
| Tube, Tissue Culture | Class 1 | test tube | 2017 | 12 |
| Urinal | Class 1 | Urinal | 2024 | 34 |
| Walker, Mechanical | Class 1 | Wheelchair | 2017 | 183 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Rollmed | FAQ | 5 |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2012 |
|---|---|
| Employees | 15 |
| Main products | Swabs, Sample collection kits, Pipette tips, PCR plates, Blood collection tubes |
| Certifications | ISO13485, CE, FDA, CFDA |
| Export markets | 50+ countries |
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.