Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010409218

FEI Number

3010409218

Entity Name

R&R Medical Corporation Ltd.

City/State/Country

Sanchong District New Taipei, TW

Establishment Address

No.4 Lane 38 ZhongXing North Street, Sanchong District New Taipei 24158, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

TAIWAN STANCH CO., LTD. (Owner Number: 9026133)

Owner / Operator Contact Address

No.99 Sec.1 Xintai 5th Road, 30F, Unit 06, New Taipei City - Xizhi District, TW-NOTA 22175, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

X-Y Lubricating Jelly

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2003-03-13
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2014-04-16
IKY	Mattress, Flotation Therapy, Non-Powered	General Hospital	Class 1	880.5150	2006-09-14
KTC	Bath, Sitz, Nonpowered	Physical Medicine	Class 1	890.5125	2006-09-14
HED	Douche Apparatus, Vaginal, Therapeutic	Obstetrics/Gynecology	Class 1	884.5900	1996-05-23
NUC	Lubricant, Personal	Obstetrics/Gynecology	Class 2	884.5300	2023-03-30
KYR	Bag, Ice	General Hospital	Class 1	880.6050	2003-03-13
OMW	Adhesive Backed Thermal Skin Patches	Physical Medicine	Class 1	890.5710	2018-02-07
ILE	Sling, Arm, Overhead Supported	Physical Medicine	Class 1	890.3475	2014-04-07
FOH	Mattress, Water, Temperature Regulated	General Hospital	Class 1	880.5560	2006-09-14
KYS	Insoles, Medical	General Hospital	Class 1	880.6280	2006-09-14
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2014-04-07
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	1999-08-25
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2014-04-07
FCE	Enema Kit	Gastroenterology, Urology	Class 1	876.5210	2006-10-16
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2014-04-07

Official Correspondent

No official correspondent registered.

US Agent Details

Wilson Chang Email: wcchang@taiwanstanch.com Phone: (512) 7889037

Related Public Records

Same Entity

TAIWAN STANCH 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
K880871	John Wagner Associates, Inc.	GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER	1988-05-20
K050212	Qualis, Inc.	PERSONAL WARMING JELLY	2005-03-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0505-2022	Philips North America Llc	1	Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022	Philips North America Llc	1	Infant Heel Warmers w/strap, Reference # 989805603201 1223

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3008742818	PT. Hisamitsu Pharma Indonesia	Sidoarjo Jawa Timur, ID

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010409218. Last updated year: 2026. Please use registration number 3010409218 when referencing this establishment in official correspondence.