FDA Registration
Active
🇹🇼 Taiwan
R&R Medical Corporation Ltd.
Reg #: 3010409218
·
FEI: 3010409218
·
Expires 2026
Products
24
Proprietary Names
2
Establishment Types
5
Classifications
24
Registration Details
- Registration Name
- R&R Medical Corporation Ltd.
- Registration Number
- 3010409218
- FEI Number
- 3010409218
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.4 Lane 38 ZhongXing North Street
- City
- Sanchong District New Taipei
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K220226
Owner / Operator
- Firm Name
- TAIWAN STANCH CO., LTD.
- Operator Number
- 9026133
- Address
- No.99 Sec.1 Xintai 5th Road, 30F, Unit 06
- City
- New Taipei City - Xizhi District
- State
- TW-NOTA
- Postal Code
- 22175
- Country
- TW
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pack, Hot Or Cold, Disposable | IMD | Class 1 | Physical Medicine | No | 2003-03-13 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2014-04-16 |
| Mattress, Flotation Therapy, Non-Powered | IKY | Class 1 | General Hospital | No | 2006-09-14 |
| Bath, Sitz, Nonpowered | KTC | Class 1 | Physical Medicine | No | 2006-09-14 |
| Douche Apparatus, Vaginal, Therapeutic | HED | Class 1 | Obstetrics/Gynecology | No | 1996-05-23 |
| Lubricant, Personal | NUC | Class 2 | Obstetrics/Gynecology | No | 2023-03-30 |
| Bag, Ice | KYR | Class 1 | General Hospital | No | 2003-03-13 |
| Adhesive Backed Thermal Skin Patches | OMW | Class 1 | Physical Medicine | No | 2018-02-07 |
| Sling, Arm, Overhead Supported | ILE | Class 1 | Physical Medicine | No | 2014-04-07 |
| Mattress, Water, Temperature Regulated | FOH | Class 1 | General Hospital | No | 2006-09-14 |
| Insoles, Medical | KYS | Class 1 | General Hospital | No | 2006-09-14 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2014-04-07 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 1999-08-25 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2014-04-07 |
| Enema Kit | FCE | Class 1 | Gastroenterology, Urology | No | 2006-10-16 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2014-04-07 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2022-12-28 |
| Support, Arm | IOY | Class 1 | Physical Medicine | No | 2014-04-07 |
| Cushion, Flotation | KIC | Class 1 | Physical Medicine | No | 2007-07-24 |
| Bottle, Hot/Cold Water | FPF | Class 1 | General Hospital | No | 2006-09-14 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-06-14 |
| Splint, Extremity, Inflatable, External | FZF | Class 1 | General, Plastic Surgery | No | 2006-10-16 |
| Orthosis, Cervical | IQK | Class 1 | Physical Medicine | No | 2014-04-07 |
| Urinal | FNP | Class 1 | General Hospital | No | 2015-08-12 |
Proprietary Names
X-Y Lubricating Jelly
Latest Medical Face Mask
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device
Foreign Private Label Distributor
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device