FDA Registration
Active
🇹🇭 Thailand
INNOLATEX (THAILAND) LIMITED
Reg #: 3007829481
·
FEI: 3007829481
·
Expires 2026
Products
5
Proprietary Names
4
Establishment Types
2
Classifications
5
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Registration Details
- Registration Name
- INNOLATEX (THAILAND) LIMITED
- Registration Number
- 3007829481
- FEI Number
- 3007829481
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Lot E1-6 Export Processing Zone, Southern Industrial Estate, Village 4, Chalung
- City
- Hat Yai Songkhla
- Country
- TH
Regulatory Submissions
- 510(k) Number
- K946103
Owner / Operator
- Firm Name
- INNOLATEX SDN. BHD
- Operator Number
- 9042429
- Address
- LOT 591 & 594, PERSIARAN RAJA LUMU,, PANDAMARAN INDUSTRIAL ESTATE,
- City
- PORT KLANG
- State
- Selangor
- Postal Code
- 42000
- Country
- MY
- Correspondent
- GOH MIAH KIAT
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Condom | HIS | Class 2 | Obstetrics/Gynecology | No | 2019-07-08 |
| Lubricant, Personal | NUC | Class 2 | Obstetrics/Gynecology | No | 2026-01-13 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2024-01-08 |
| Condom, Synthetic | MOL | Class 2 | Obstetrics/Gynecology | No | 2025-05-07 |
| Barrier, Std, Oral Sex | MSC | Class 2 | Obstetrics/Gynecology | No | 2026-01-15 |
Proprietary Names
myONE Perfect Fit
CVS
Walgreen
One Vanish
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device