Is this your brand? Sign in to claim ownership.
Sign in to claim this brandTOMY International, Inc.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 45 Shawmut Rd, Canton, MA, 02021
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 1217805
- DUNS Number
- —
Catalogue (22)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| The First Years | Y7957 | FDA UDI | N/A | Unknown |
| Lamaze/John Deere | L27412 | FDA UDI | Class II | Active |
| American Red Cross | Y7054 | FDA UDI | Class II | Unknown |
| The First Years | Y7078A6 | FDA UDI | Class II | Active |
| American Red Cross | Y7916 | FDA UDI | Class II | Unknown |
| American Red Cross | Y7825 | FDA UDI | Class II | Unknown |
| Boon | B11185 | FDA UDI | Class II | Active |
| The First Years | Y7057A5 | FDA UDI | N/A | Active |
| American Red Cross | Y7078 | FDA UDI | Class II | Unknown |
| The First Years | Y6228 | FDA UDI | Class II | Unknown |
| The First Years | Y7078A8 | FDA UDI | Class II | Active |
| The First Years | Y6053 | FDA UDI | Class II | Unknown |
| The First Years | Y7078A7 | FDA UDI | Class II | Active |
| Lamaze | L27619 | FDA UDI | Class II | Unknown |
| Lamaze | Y5228L | FDA UDI | Class II | Unknown |
| American Red Cross | Y7790 | FDA UDI | Class II | Unknown |
| The First Years | Y5288 | FDA UDI | Class II | Unknown |
| American Red Cross | Y7054, Y7057 | FDA UDI | Class II | Unknown |
| American Red Cross | Y7149 | FDA UDI | Class II | Unknown |
| American Red Cross | Y10896 | FDA UDI | Class II | Unknown |
| The First Years | Y7051 | FDA UDI | Class II | Active |
| Memory Pump Model Y4947 | K131027 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Dec 2, 2022 | Z-0766-2023 | — | open, classified | 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. |