UDI device identifier
Equaline Early Result Pregnancy Test
UDI device identifier 00041163502963 · SPD SWISS PRECISION DIAGNOSTICS GMBH
Key facts
| Primary DI | 00041163502963 |
|---|---|
| Brand name | Equaline |
| Version or model | Early Result Pregnancy Test |
| Company | SPD SWISS PRECISION DIAGNOSTICS GMBH |
| DUNS number | 483609579 |
| Product code | LCX |
| GMDN term | Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical |
| Premarket submission | K042280 |
| Device class | Class II |
| Single use | Yes |
| Packaged sterile | No |
| Implantable | No |
| Publish date | Apr 19, 2021 |
| Version date | Feb 6, 2024 |
| Description | Equaline SPS Early Result |
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: