Lamaze
Water Filled Chill Teethers
18manufacturers in China registered for this device type
2catalogue numbers in this listing
7recalls on this code
Who Else Makes It
Concentrated in Guangdong (11), Zhejiang (2), Hebei (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Essentia Industries Ltd. | Dong Guan | Guangdong | Contract manufacturer | 31 |
| Foshan City Shunde Jiajun Plastic & Hardware Products Co Ltd | Foshan | Guangdong | Contract manufacturer | 11 |
| Huizhou Xinghuayuan Houseware Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 3 |
| He Gao Plastic Factory | Shantou | Guangdong | Contract manufacturer | 2 |
| Treasure Baby Toys (Dongguan) Limited | Dongguan | Guangdong | Contract manufacturer | 1 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Ningbo Raffini Import & Export Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 19 |
| Gavin Biotechnology Co., Ltd. | Jinzhong | Shanxi | Manufacturer | 16 |
| Elung Industrial Co., Ltd. | T.S.T.,Kowloon | Hong Kong | Exporter | 14 |
| Hubei Xinyunqi Household Products Co., Ltd. | Tongshan | Hubei | Manufacturer | 11 |
| Solid Toys IND. Ltd. | Boluo County, Huizhou,City | Guangdong | Contract manufacturer | 8 |
| Dongguan Qing Xi Essentia Industries Ltd | Dongguan | Guangdong | Manufacturer | 8 |
Showing 12 of 18. All 18 manufacturers in China registered for Ring, Teething, Fluid-Filled
Record
| Listed by | Tomy International, United States |
|---|---|
| FDA product code | KKO |
| Device type | Ring, Teething, Fluid-Filled |
| Device class | Class 2 |
| Regulation | 21 CFR 872.5550 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-10-11 |
| Record revised | 2025-06-20 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date |
| Packaging | Master carton of 4, inner carton of 6, retail package, master of 4, retail of 2, master of 3 |
| Distribution end date | 2025-01-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Y5228L | Withdrawn | |
| L27619 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Nuby | LUV N’ Care, Ltd. | 19 |
| Green Sprouts | O2cool, LLC | 13 |
| Sassy | Sassy Baby, Inc | 11 |
| Bright Starts | Kids II, Inc. | 10 |
| Dr. Brown’s | Dr. Brown’s Company | 7 |
| Baby Einstein | Kids II, Inc. | 6 |
| MAM | Mam USA Corporation | 6 |
| Momcozy | Shenzhen Lutejiacheng Supply Chain Management Co., Ltd. | 2 |
| Sesame Beginnings | Regent Baby Products Corp. | 2 |
| Ingenuity | Kids II, Inc. | 2 |
| Fun Ice Ring Teether- 2pk | Munchkin Inc. | 1 |
| Always My Baby | LUV N’ Care, Ltd. | 1 |
Showing 12 of 25. All products under Ring, Teething, Fluid-Filled
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Tomy International | UDI-DI | 2022-12-02 | Class II | Process control | Affected lots of the product are being recalled due to potential microbial growth in the fluid inside the device. if a compromised product is used by a child with a weakened immune system, an infection or other illness could occur. | approx 55,000 North America |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Closed |
|---|---|---|---|---|
| 2006-01-25 | Not classified | Other | Liquid Filled Infant teething ring contaminated with Pseudomonas aeruginosa and Pseudomonas putida | 2006-08-10 |
| 2006-01-25 | Not classified | Other | Liquid Filled Infant teething ring contaminated with Pseudomonas aeruginosa and Pseudomonas putida | 2006-08-10 |
| 2006-01-25 | Not classified | Other | Liquid Filled Infant teething ring contaminated with Pseudomonas aeruginosa and Pseudomonas putida | 2006-08-10 |
| 2006-01-25 | Not classified | Other | Liquid Filled Infant teething ring contaminated with Pseudomonas aeruginosa and Pseudomonas putida | 2006-08-10 |
| 2006-01-25 | Not classified | Other | Liquid Filled Infant teething ring contaminated with Pseudomonas aeruginosa and Pseudomonas putida | 2006-08-10 |
| 2006-01-25 | Not classified | Other | Liquid Filled Infant teething ring contaminated with Pseudomonas aeruginosa and Pseudomonas putida | 2006-08-10 |
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.