UDI device identifier
Topcare Early Ovulation Test
UDI device identifier 00036800493919 · Topco Associates, LLC
Key facts
| Primary DI | 00036800493919 |
|---|---|
| Brand name | Topcare |
| Version or model | Early Ovulation Test |
| Company | Topco Associates, LLC |
| DUNS number | 072943876 |
| Product code | CEP |
| GMDN term | Natural conception assistance kit |
| Premarket submission | K042280 |
| Device class | 1 | 2 |
| Single use | Yes |
| Packaged sterile | No |
| Implantable | No |
| Publish date | Mar 7, 2022 |
| Version date | Sep 18, 2024 |
| Description | A convenience kit consisting of 10 Topcare Ovulation Tests and 1 Topcare Pregnancy Test |
At a glance
- None MAUDE reports citing this UDI
- Yes Linked premarket submission
- No EUDAMED counterpart found
- 100–999 GUDID devices with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About UDI device identifiers (GUDID)
The Global Unique Device Identification Database (GUDID) holds the device identifiers (UDI-DIs) and key attributes that labelers submit to the FDA for devices that carry a unique device identifier.
Source: U.S. FDA Global Unique Device Identification Database (GUDID), via NLM AccessGUDID · Source date: