FDA Registration
Active
🇺🇸 United States
Rael, Inc.
Reg #: 3013354376
·
FEI: 3013354376
·
Expires 2026
Products
10
Proprietary Names
39
Establishment Types
2
Classifications
10
Registration Details
- Registration Name
- Rael, Inc.
- Registration Number
- 3013354376
- FEI Number
- 3013354376
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 6940 Beach Blvd. D-301
- City
- Buena Park
- State
- CA
- ZIP
- 90621
- Country
- US
Regulatory Submissions
- 510(k) Number
- K152284
Owner / Operator
- Firm Name
- Rael, Inc.
- Operator Number
- 10053897
- Address
- 6940 Beach Blvd. D-301
- City
- Buena Park
- State
- CA
- Postal Code
- 90621
- Country
- US
- Correspondent
- Binna Won
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2018-07-24 |
| Pad, Menstrual, Reusable | NUQ | Class 1 | Obstetrics/Gynecology | No | 2017-03-10 |
| Tampon, Menstrual, Unscented | HEB | Class 2 | Obstetrics/Gynecology | No | 2017-11-30 |
| Pad, Menstrual, Unscented | HHD | Class 1 | Obstetrics/Gynecology | No | 2017-03-10 |
| Tampon, Menstrual, Scented, Scented-Deodorized | HIL | Class 2 | Obstetrics/Gynecology | No | 2021-05-18 |
| Nursing Pad, Cohesive Gel | NXH | Class 1 | General Hospital | No | 2020-01-14 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2018-07-24 |
| Garment, Protective, For Incontinence | EYQ | Class 1 | Gastroenterology, Urology | No | 2017-03-10 |
| Cup, Menstrual | HHE | Class 2 | Obstetrics/Gynecology | No | 2017-03-22 |
| Pack, Hot Or Cold, Disposable | IMD | Class 1 | Physical Medicine | No | 2018-12-14 |
Proprietary Names
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
Rael Organic Cotton Reusable Pads (Pantyliners, Slim, Regular, Large, Overnight)
Rael Reusable Period Underwear - High Waist - Small, Medium, Large, XLarge, XXLarge
Rael Reusable Period Underwear - Bikini - Small, Medium, Large, XLarge, XXLarge
Rael Reusable Period Underwear - Boyshorts - Small, Medium, Large, XLarge, XXLarge
Rael Organic Cotton No-applicator Tampons - Regular 18
Rael Organic Cotton No-applicator Tampons - Super 18
Rael Compact Tampon
Rael organic cotton pads - Regular
Rael organic cotton pads - Overnight
Rael organic cotton pads - Large
Rael organic cotton pads - Petite
Rael Organic Cotton Cover Period Underwear L-XL
Rael Organic Panty Liner - Long
Rael Organic Panty Liner - Regular
Rael Organic Cotton Cover Pads - Extra Long Overnight
Rael Micro Thin Organic Cotton Cover Daily Liners - Regular
Rael Organic Cotton Cover Period Underwear S-M
Rael Organic Cotton Cover Panty Liners Extra Long
Rael Organic Cotton tampons with Plant-Based plastic Applicators- Regular+Super
Rael Organic Cotton tampons with Plant-Based plastic Applicators- Super
Rael Organic Cotton tampons with Plant-Based plastic Applicators- Regular
Rael Organic Cotton Cover Incontinence Pads-Ultimate
Rael Organic Cotton Cover Incontinence Pads-Moderate
Rael Organic Cotton Cover Incontinence Liners-Regular
Rael Organic Cotton Cover Incontinence Liners-Long
Rael Beauty Miracle Patch Microcrystal Spot Cover
Rael Miracle Patch Dark spot Cover 6ct
Rael Organic Cotton Reusable Pads for Bladder Leaks (Slim, Medium, Large, Overnight)
Rael Menstrual Cup
Rael Tampon
Rael Organic Cotton Cardboard Applicator Tampons - Super
Rael Organic Cotton Cardboard Applicator Tampons - Regular
Rael Natural Herbal Heating Patch
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility