Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010160370

FEI Number

3010160370

Entity Name

Hebei Ruinuo Medical Instrument Co Ltd

City/State/Country

Shijiazhuang Hebei, CN

Establishment Address

No. 55 Kunlun Street, Shijiazhuang, High & New Technology Industry, Shijiazhuang Hebei 050035, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Hebei Ruinuo Medical Instrument Co., Ltd (Owner Number: 10042257)

Owner / Operator Contact Address

No. 55 Kunlun Street, Shijiazhuang High&New, Technology Industry Development Zone, Shijiazhuang, CN-HE 050035, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Nonpneumatic tourniquet Disposable Medical Pad Disposable Surgical Hole Towel Disposable Medical Treatment Towel Elastic Bandage Silicone Scar Sheets Hot/Cold Gel Pack Cold Compression Wrap Skin Marker Adhesive Bandages Drainage tube fixation device Carbon Fiber Wound Dressings Sterile Alginate Dressings Medical Face Shield Medical Safety Goggles Disposable Medical Wrapping Cloth Disposable Non Woven Shoe Cover Disposable Medical Protective Clothing Disposable Medical Isolation Coverall Examination Gowns Limbs Fixing Splint Orthopedic Splint Abdominal Binders Drainage Bag Disposable Medical Isolation Gown Nasal Cannulas Medical Cold Therapy System Sterile Transparent Dressings Sterile Adhesive Wound Dressings Disposable Suction Tube High Negative Pressure Drainage Bottle Disposable Suction Reservoir and Flat Drain Medical Negative Pressure Drainage Device Thoracic drainage bottle

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2012-11-05
ERY	Drape, Surgical, Ent	General, Plastic Surgery	Class 2	878.4370	2020-03-09
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2012-11-05
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	2014-06-04
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2019-04-18
FZZ	Marker, Skin	General, Plastic Surgery	Class 1	878.4660	2013-09-11
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2012-11-05
EYJ	Holder, Ureteral Catheter	Gastroenterology, Urology	Class 1	876.5130	2012-11-05
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2013-09-11
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-07-27
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	2020-03-09
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2020-03-09
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-03-09
FME	Gown, Examination	General Hospital	Class 1	880.6265	2020-03-09
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile	General, Plastic Surgery	Class 1	878.3910	2012-11-05
FSD	Binder, Abdominal	General Hospital	Class 1	880.5160	2012-11-05
FON	Bag, Drainage, With Adhesive, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2012-11-05
FME	Gown, Examination	General Hospital	Class 1	880.6265	2020-03-09
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2013-09-11
ILO	Pack, Hot Or Cold, Water Circulating	Physical Medicine	Class 2	890.5720	2014-02-13
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2013-09-11
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2013-09-11
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2012-11-05

Official Correspondent

No official correspondent registered.

US Agent Details

Mark Gordon Email: Mark.W.Gordon@outlook.com Phone: (920) 6019045

Related Public Records

Same Entity

Hebei Ruinuo Medical Instrument 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
K831798	I M, Inc.	DISPOSABLE SCALPELS	1983-07-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019	COVIDIEN LLC	1	Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0016-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0017-2019	COVIDIEN LLC	1	Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010160370. Last updated year: 2026. Please use registration number 3010160370 when referencing this establishment in official correspondence.