Dong-A Pharmaceutical Co., Ltd.
The Tempo Natural Tampon is intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge.
10manufacturers in China registered for this device type
4catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (2), Fujian (2), Shandong (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Foshan Niceday Sanitary Products Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 19 |
| Fujian Time AND Tianhe Industrial Co., Ltd. | Nanan | Fujian | Contract manufacturer | 9 |
| Guangdong Bingbing Health Care Products Ltd. | Jiangmen | Guangdong | Repacker / relabeller | 7 |
| Fujian Tonggang Industries Ltd. | Quanzhou | Fujian | Manufacturer | 6 |
| Shandong Intco Hygiene Products Co., Ltd. | Zibo | Shandong | Contract manufacturer | 2 |
| Eisungrain (Shandong) Eco Technology Co., Ltd. | Zibo | Shandong | Exporter | 2 |
| Unibeauty (Hubei) Technology Co., Ltd. | Xiantao | Hubei | Manufacturer | 1 |
| Suzhou Borage Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 1 |
| Zhejiang Tianqing Manufacturing Technology Group Co., Ltd. | Huzhou | Zhejiang | Specification developer | 1 |
| Hangzhou Pengtu Chemical Fiber Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 1 |
Record
| Listed by | Dong-A Pharmaceutical Co., Ltd., South Korea |
|---|---|
| FDA product code | HEB |
| Device type | Tampon, Menstrual, Unscented |
| Device class | Class 2 |
| Regulation | 21 CFR 884.5470 |
| Establishment | Private-label distributor |
| Record published | 2023-02-14 |
| Record revised | 2024-04-08 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Tempo Natural Tampon Regular | In distribution | |
| Tempo Natural Tampon Super | In distribution | |
| Tempo Tampon Regular | In distribution | |
| Tempo Tampon Super | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tampax | Procter & Gamble Manufacturing Company, THE | 509 |
| U By Kotex | Kimberly-Clark Global Sales, Inc. | 185 |
| Playtex | Edgewell Personal Care Brands, LLC | 71 |
| Cora | Cora | 66 |
| CVS Health Tampons | Woonsocket Prescription Center, Incorporated | 61 |
| This is L | Procter & Gamble Manufacturing Company, THE | 46 |
| Walgreens | Walgreen Co. | 38 |
| Daye | Tampon Innovations Ltd OOD | 34 |
| H-E-B Tampons | H. E. Butt Grocery Company | 32 |
| Rite Aid Tampons | AL-BAD Massuot Yitzhak Ltd | 28 |
| DG Health Tampons | Dolgencorp, LLC | 23 |
| Kroger Tampons | Kroger Co., THE | 22 |
Showing 12 of 161. All products under Tampon, Menstrual, Unscented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K212277 | 2022-04-21 |
| K212272 | 2021-09-17 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.