UDI device identifier
SURESIGN™ Early Detection Pregnancy Test + Digital Pregancy Rapid Test 01003-1
UDI device identifier 00045611010031 · Guangzhou Decheng Biotechnology Co., LTD
Key facts
| Primary DI | 00045611010031 |
|---|---|
| Brand name | SURESIGN™ Early Detection Pregnancy Test + Digital Pregancy Rapid Test |
| Version or model | 01003-1 |
| Company | Guangzhou Decheng Biotechnology Co., LTD |
| DUNS number | 554534314 |
| Product code | LCX |
| GMDN term | Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical |
| Premarket submission | K222305 |
| Device class | Class II |
| Single use | Yes |
| Packaged sterile | No |
| Implantable | No |
| Publish date | Jan 28, 2026 |
| Version date | Feb 5, 2026 |
| Description | 1ct 10mIU Early Detection Pregnancy Test +1ct 25mIU Digital Pregancy Rapid 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: