FDA Registration
Active
🇰🇷 South Korea
RAEL KOREA CO., LTD.
Reg #: 3015375647
·
FEI: 3015375647
·
Expires 2026
Products
7
Proprietary Names
22
Establishment Types
1
Classifications
7
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Registration Details
- Registration Name
- RAEL KOREA CO., LTD.
- Registration Number
- 3015375647
- FEI Number
- 3015375647
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 446 Bongeunsa-ro, Spigen HQ Building A
- City
- Seoul
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K182814
Owner / Operator
- Firm Name
- Rael Korea Co., Ltd.
- Operator Number
- 10061090
- Address
- 446 Bongeunsa-ro, Spigen HQ Building A
- City
- Seoul
- State
- KR-11
- Postal Code
- 06153
- Country
- KR
US Agent
- Business Name
- Withus Group Inc.
- Contact Name
- April Lee
- Address
- 106 Superior
- City
- Irvine
- State
- CA
- ZIP
- 92620
- Country
- US
- [email protected]
- Phone
- 909 2749971
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Garment, Protective, For Incontinence | EYQ | Class 1 | Gastroenterology, Urology | No | 2019-08-22 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2019-09-04 |
| Pad, Menstrual, Unscented | HHD | Class 1 | Obstetrics/Gynecology | No | 2019-08-22 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2019-09-04 |
| Pack, Hot Or Cold, Disposable | IMD | Class 1 | Physical Medicine | No | 2019-09-04 |
| Pad, Menstrual, Reusable | NUQ | Class 1 | Obstetrics/Gynecology | No | 2019-08-27 |
| Tampon, Menstrual, Unscented | HEB | Class 2 | Obstetrics/Gynecology | No | 2019-08-15 |
Proprietary Names
Rael Organic Cotton Reusable Pads for Bladder Leaks (Slim, Medium, Large, Overnight)
Rael Beauty Miracle Patch Invisible Spot Cover
Rael Beauty Miracle Patch Spot Control Cover
Rael Miracle Patch XL Spot control cover
Rael Miracle Patch Overnight Spot Cover
Rael MIRACLE PATCH DUO Invisible Spot Cover + Spot Control Cover
Advanced Strength Retinol Spot Cover
Pad - Petite
Liner - Long
Pad - Regular
Pad - Overnight
Liner - Regular
Pad - Large
Rael Ultra Secure Period Underwear (L-XL)
Rael Ultra Secure Period Underwear (S-M)
Rael Organic Cotton Cover Panty Liners Extra Long
Rael Beauty Miracle Patch Microcrystal Spot Cover
Rael Miracle Patch Dark spot Cover 6ct
HERBAL HEATING PATCH (Period Cramp Relief)
Rael Organic Cotton Reusable Pads (Pantyliners, Slim, Regular, Large, Overnight)
BPA Free Tampon_Regular
BPA Free Tampon_Super
Establishment Types
Export Device to the United States But Perform No Other Operation on Device