Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013530901

FEI Number

3013530901

Entity Name

HANGZHOU ROLLMED CO.,LTD.

City/State/Country

Hangzhou Zhejiang, CN

Establishment Address

Room 913, Yuanmao Mansion No.5,, Wen Er West Road, Xihu district,, Hangzhou Zhejiang 310012, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Hangzhou Rollmed Co.,Ltd. (Owner Number: 10053608)

Owner / Operator Contact Address

Room 913, Yuanmao Mansion No.5,, Wen Er West Road, Xihu district,, Hangzhou, CN-ZJ 310012, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Triangular Bandage Colostomybag, Crusher, Spur, Colostomy Nonrebreathing mask Vaginal Speculum Knee/Elbow adhesive Plaster,60*100MM latex free First Tape Roll Adhesive Plaster, L,Latex Circle Adhesive plaster,Latex free Knee/Elbow adhesive Plaster,c Adhesive Plaster, S,Latex MGO 6cm*7cm;5cm*5cm;10cm*10cm;10cm*15cm;10cm*20cm;10cm*25cm;10cm*30cm JUNIOR Adhesive, M TAPE AND BANDAGE, ADHESIVE, Ostomy Abdomen Belt, PocketBelt Knee/Elbow adhesive Plaster,Latex Knee/Elbow adhesive Plaster,M Adhesive Plaster, M,Latex Adhesive Plaster, L Knee/Elbow adhesive Plaster,80*100MM latex free Fingertip adheisve plaster /Knuckle Plaster Circle Adhesive plaster,Latex ADHESIVE DRESSING Knee/Elbow adhesive Plaster,60*100MM Adhesive Plaster, M Butterfly adhesive plaster,76*38/PE LATEX Knee/Elbow adhesive Plaster,L Confirmation bandage Knee/Elbow adhesive Plaster,50*100mm,Latex Butterfly adhesive plaster Adhesive Plaster, S urine container/stool container/Embedding cassettes COVID-19(SARS-CoV-2)IgM/IgG Antibody Test Kit(Colloidal Gold) COVID-19(SARS-CoV-2)Ig M Antibody Test Kit(Colloidal Gold) COVID- 19(SARS-CoV-2)IgG Antibody Test Kit(Colloid al Gold) ROLLMED Wheelchair ROLLMED pipette tips transfer pipette Flask Beaker Cell Culture Flask; Cell Culture Plate; Deep Well Plate; Dish; Elisa Plate; Pcr Plate; Storage Bottle Urinal colostomy bag BAG, DRAINAGE, WITH ADHESIVE, OSTOMMY Wound plaster Wheelchair Scale dental floss pick C Wheelchair Goggles test tube Colostomy bag, Rod, Colostomy centrifuge/centrifuge tube Vaginal speculum Vaginal Speculum ROLLMED vacuum blood tube Stethoscope MET Adaptor, Ureteral Catheter, Wrological catheter and accessories ROLLMED Wheelchair Wheelchair Mask, Face Mask, Nonwoven Face Mask, Disposable Medical face Mask,Daily protective mask, N95 protective mask Disposable Medical Face Mask Mask Daily Protective Mask N95 Protective Mask Face Mask Nonwoven Face Mask STRIP CAP stethoscope Breathing Trainer Metal Tweezer Cylinder swab applicator Applicator, Absorbent Tipped, Sterile Vaginal Speculum wooden tongue depressors colostomy bag Baby scale Wheelchair stethoscope singel-use container for human venous blood specimen collection suction liner Oropharyngeal Airway Wheelchair Vaginal Speculum Bouin's-Collect FIuid,VTM-N Collection and Transport Kit VTM Collection and Transport Kit ,Container, Specimen mailer and storage, sterile ROLLMED Vaginal Speculum Wheelchair Wheelchair bandage Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4 suction liner swab applicator Cervical specimen collection Flocked swab specimen collection Foam swab, Specimen collection polyester swab Nasopharyngeal Flocked swab, Oropharyngeal Flocked swab DNA flocked swab sterile Absorbent Tipped sterile Applicator Sponge Swab,Applicator, Absorbent Tipped, Non-Sterile sterile Sponge Swab Cotton Swab Wheelchair ROLLMED BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, NON-STERILE Wheelchair scale Burn Care Medcine cup Antigens, Ha (Including Ha Control), Influenza Virus A, B, C FIT test cassette(stool occulit blood) Antigens, Cf (Including Cf Control), Influenza Virus A, B, C Pasteur Pipette; Pcr Tube; Pipette Tips; Sample Vials; Syringe Filter Centrifuge Tube; Cryopreservation Tube; Microcentrifuge Tube Pasteur Pipette Sample Vials Pipette Tips PCR Tube Cryopreservation Tube Microcentrifuge Tube Syringe Filter Centrifuge Tube silicone scar sheet petri dish ROLLMED ROLLMED ptfe megnetic stir bar Tourniquet Sterile Gauze Pad 4*4/12 PLY Sterile Gauze Pad 2*2/8 PLY Sterile Gauze Pad 3*3/12 PLY ROLLMED shoe cover FEVER COOLING PATCH COLLECTOR, OSTOMY saliva ejector CEMENT, STOMAL APPLIANCE, OSTOMY, Ostomy Cream, SkinBarrier Strip, Ostomy Fastened Ring ROLLMED eyp pad EYE PAD, Adult EYE PAD, Child Wheelchair Wheelchair Influenza A&B suction liner colostomy bag Wheelchair Wheelchair bandage

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2025-06-09
FHH	Crusher, Spur, Colostomy	Gastroenterology, Urology	Class 1	876.4730	2024-12-23
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2018-11-29
HDG	Speculum, Vaginal, Metal, Fiberoptic	Obstetrics/Gynecology	Class 1	884.4520	2024-01-09
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2017-12-04
KER	Container, Embedding	Pathology	Class 1	864.3010	2017-01-22
QKO	Reagent, Coronavirus Serological	Unknown	Class N	N/A	2020-03-24
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2016-12-21
IMX	Board, Lap, Wheelchair	Physical Medicine	Class 1	890.3910	2017-12-06
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2016-12-21
JRC	Micro Pipette	Clinical Chemistry	Class 1	862.2050	2017-01-22
KJA	Flask, Tissue Culture	Hematology	Class 1	864.2240	2018-11-29
FNP	Urinal	General Hospital	Class 1	880.6730	2024-05-24
FON	Bag, Drainage, With Adhesive, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2023-05-09
MGO	Closure, Wound, Adhesive	General, Plastic Surgery	Class 1	878.4018	2017-12-06
INA	Hill Holder, Wheelchair	Physical Medicine	Class 1	890.3920	2017-12-06
FRI	Scale, Stand-On, Patient	General Hospital	Class 1	880.2700	2018-11-21
JES	Floss, Dental	Dental	Class 1	872.6390	2025-06-09
INE	Sling, Overhead Suspension, Wheelchair	Physical Medicine	Class 1	890.3910	2017-12-06
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2020-03-16
KJG	Tube, Tissue Culture	Pathology	Class 1	864.3010	2017-01-22
EZP	Rod, Colostomy	Gastroenterology, Urology	Class 2	876.4270	2024-12-23
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Clinical Chemistry	Class 1	862.2050	2017-01-22
HIB	Speculum, Vaginal, Nonmetal	Obstetrics/Gynecology	Class 2	884.4530	2018-11-22
NNZ	System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2016-12-21
GIO	Tube, Collection, Capillary Blood	Hematology	Class 1	864.6150	2017-01-22
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2018-03-14
PVD	Test, Methamphetamine, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3610	2020-03-12
EYI	Adaptor, Ureteral Catheter	Gastroenterology, Urology	Class 1	876.5130	2024-12-23
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2016-12-21
IMO	Handrim, Wheelchair	Physical Medicine	Class 1	890.3920	2017-12-06
IMZ	Holder, Crutch And Cane, Wheelchair	Physical Medicine	Class 1	890.3910	2017-12-06
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2020-03-24
EHM	Strip, Polishing Agent	Dental	Class 1	872.6010	2021-12-27
HGN	Stethoscope, Fetal	Obstetrics/Gynecology	Class 1	884.2900	2018-03-14
ION	Exerciser, Non-Measuring	Physical Medicine	Class 1	890.5370	2022-05-17
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2025-06-09
ECX	Cylinder, Compressed Gas, And Valve	Anesthesiology	Class 1	868.2700	2018-11-29
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2017-01-22
FXG	Specula Accessories	General, Plastic Surgery	Class 1	878.1800	2024-01-09
KBL	Depressor, Metal Tongue, Surgical	Ear, Nose, Throat	Class 1	874.4420	2016-12-21
EXG	Bag, Urine Collecting, Ureterostomy	Gastroenterology, Urology	Class 1	876.5900	2023-05-09
FRW	Scale, Patient	General Hospital	Class 1	880.2720	2017-12-04
IMS	Support, Head And Trunk, Wheelchair	Physical Medicine	Class 1	890.3910	2017-12-06
BZS	Stethoscope Head	Anesthesiology	Class 1	868.1930	2017-12-04
GLE	Mixer, Blood Tube	Clinical Chemistry	Class 1	862.2050	2017-01-22
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2023-05-09
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2018-11-29
PCE	Permanently Mounted Wheelchair Platform Lift	Physical Medicine	Class 2	890.3930	2017-12-06
HIC	Speculum, Vaginal, Nonmetal, Fiberoptic	Obstetrics/Gynecology	Class 2	884.4530	2024-01-09
KDT	Container, Specimen Mailer And Storage, Sterile	Pathology	Class 1	864.3250	2020-05-27
EFN	Cotton, Roll	Dental	Class 1	872.6050	2016-12-21
EPY	Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	2024-01-09
INB	Attachment, Commode, Wheelchair	Physical Medicine	Class 1	890.3920	2017-12-06
IMR	Device, Anti-Tip, Wheelchair	Physical Medicine	Class 1	890.3920	2017-12-06
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2017-12-04
GQS	Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4	Microbiology	Class 1	866.3400	2020-03-12
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	2023-05-09
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2017-01-22
KHY	Cane, Safety Walk	Physical Medicine	Class 1	890.3075	2017-12-06
EPE	Brush, Cleaning, Tracheal Tube	Anesthesiology	Class 1	868.5795	2016-12-21
NNW	Bag, Urine Collection, Leg, For External Use, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2024-12-23
KNO	Accessories, Wheelchair	Physical Medicine	Class 1	890.3910	2017-12-06
INF	Scale, Platform, Wheelchair	Physical Medicine	Class 1	890.3940	2017-12-04
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2025-06-09
KYW	Container, Liquid Medication, Graduated	General Hospital	Class 1	880.6430	2017-01-22
GNT	Antigens, Ha (Including Ha Control), Influenza Virus A, B, C	Microbiology	Class 1	866.3330	2020-03-12
DDZ	Albumin, Fitc, Antigen, Antiserum, Control	Immunology	Class 2	866.5040	2020-03-12
GNX	Antigens, Cf (Including Cf Control), Influenza Virus A, B, C	Microbiology	Class 1	866.3330	2020-03-12
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2020-11-05
PFP	Silicone Hydrogel For Scar Management	General, Plastic Surgery	Class 1	878.4025	2023-05-09
KIZ	Dish, Tissue Culture	Hematology	Class 1	864.2240	2017-01-22
IQB	Belt, Wheelchair	Physical Medicine	Class 1	890.3920	2017-12-06
FYE	Dress, Surgical	General, Plastic Surgery	Class 1	878.4040	2016-12-21
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2016-12-21
JRQ	Shaker/Stirrer	Clinical Chemistry	Class 1	862.2050	2017-01-22
EYR	Tourniquet, Gastro-Urology	General, Plastic Surgery	Class 1	878.5900	2018-11-22
PKD	Laceration Tray	General, Plastic Surgery	Class 1	878.4014	2025-06-09
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2016-12-21
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2025-06-09
EXB	Collector, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2024-12-23
DYN	Mouthpiece, Saliva Ejector	Dental	Class 1	872.6640	2017-12-04
EZR	Cement, Stomal Appliance, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2024-12-23
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2016-12-21
HMP	Pad, Eye	General, Plastic Surgery	Class 1	878.4440	2017-12-04
IMM	Footrest, Wheelchair	Physical Medicine	Class 1	890.3920	2017-12-06
IMN	Climber, Curb, Wheelchair	Physical Medicine	Class 1	890.3920	2017-12-06
GQR	Antigens, Ha (Including Ha Control), Parainfluenza Virus 1-4	Microbiology	Class 1	866.3400	2020-03-12
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2023-05-09
GDS	Bag, Stomal	Gastroenterology, Urology	Class 1	876.5900	2023-05-09
KID	Restraint, Wheelchair, Non-Protective	Physical Medicine	Class 1	890.3910	2017-12-06
IMW	Brake, Extension, Wheelchair	Physical Medicine	Class 1	890.3920	2017-12-06
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2017-12-04

Official Correspondent

Martin LAI

US Agent Details

hui hong Business: ABMED MEDICAL TECHNOLOGY INC Email: info@abmed.us Phone: (509) 5816099

Related Public Records

Same Entity

Hangzhou Rollmed Co.,Ltd.

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
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04
K882164	Arthur Blank & Co., Inc.	FLOSS CARD	1988-06-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-04	Vital Concepts, Inc.	1	Huntington Instruments brand Irrigation Aspiration System with Single Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55040. Labeled as Manufactured for Huntington Instruments, Ogden Utah.
Z-0021-04	Vital Concepts, Inc.	1	Irrigation Aspiration System with Double Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55060. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan. Huntington Instruments brand labeled as Manufactured for Huntington Instruments, Ogden Utah. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ. Catalogue # 55060-10 sold in Canada and labeled as Manufactured for Jac-Cell Medic, Dorval, Quebec.
Z-0022-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Irrigation Aspiration System with double Spike Tubing, no Probe, Disposable (single use only), sterile, latex free. Catalog # 55160. Vital Concepts, Inc., Grand Rapids, Michigan.
Z-0023-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Suction-Irrigation System without Probe, Disposable (single use only), sterile, latex free. R-Med Re-Order # 55170R; Distributed by R-Med, Inc., Orgeon, OH
Z-0024-04	Vital Concepts, Inc.	1	Quanta Technologies L.L.C. brand REORDER # LAPKIT 3. Contents 1 -55060 Suction/Irrigation Valve 2- 30012 Insufflation Tubing set 3- 5010 Anti Fog Solution with Sponge. Manufactured for Quanta Technologies, L.L.C., Tucson, AZ.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013530901. Last updated year: 2026. Please use registration number 3013530901 when referencing this establishment in official correspondence.