R&R Medical Corporation Ltd.
Sanchong District New Taipei, TW
R&R Medical Corporation Ltd. appears in FDA device records in Sanchong District New Taipei, TW. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for R&R Medical Corporation Ltd. between 2005 and 2023. The busiest year on record is 2005, with 2. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 2 |
| 2022 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K220226 | X-Y Lubricating Jelly | NUC | Substantially Equivalent | |
| K214035 | LAITEST Medical Face Mask | FXX | Substantially Equivalent | |
| K052005 | R&R EXTERNAL FIXATION SYSTEM | KTT | Substantially Equivalent | |
| K043174 | STEALTH FUSION SYSTEM, MODEL RR 1000 | KTT | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3010409218 | 3010409218 | R&R Medical Corporation Ltd. | No.4 Lane 38 ZhongXing North Street, Sanchong District New Taipei 24158 TW | 2026 | and 14 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LYUAccessory, Surgical Apparel
- OMWAdhesive Backed Thermal Skin Patches
- KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- KYRBag, Ice
- KTCBath, Sitz, Nonpowered
- FPFBottle, Hot/Cold Water
- KICCushion, Flotation
- HEDDouche Apparatus, Vaginal, Therapeutic
- FCEEnema Kit
- KYSInsoles, Medical
- ITWJoint, Ankle, External Brace
- ITQJoint, Knee, External Brace
- NUCLubricant, Personal
- FXXMask, Surgical
- IKYMattress, Flotation Therapy, Non-Powered
- FOHMattress, Water, Temperature Regulated
- IQKOrthosis, Cervical
- IQIOrthosis, Limb Brace
- IMDPack, Hot Or Cold, Disposable
- IMEPack, Hot Or Cold, Reusable
- ILESling, Arm, Overhead Supported
- FZFSplint, Extremity, Inflatable, External
- ILHSplint, Hand, And Components
- IOYSupport, Arm
- FNPUrinal
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets R&R Medical Corporation Ltd. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain