Data / Medical devices / China / Zhejiang UE Medical Corp.
Zhejiang UE Medical Corp.: FDA-registered device maker in Xianju Zhejiang, China, 1 510(k) clearance
Zhejiang UE Medical Corp. is registered with the FDA (registration 3010396739) in Xianju Zhejiang, China. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 11, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3010396739
- Address
- 8 Youyi Road Baita Economic Development Zone, Xianju Zhejiang, China, 317300
- Owner or operator
- Zhejiang UE Medical Corp. (10044022)
- Roles
- Manufacturer
- First device listed
- April 19, 2013
- Registered through
- 2027
- Brand names listed
- Disposable Medical Laryngeal Masks, DLM10, DLM15, DLM20, DLM25, DLM30, DLM40, DLM50, DLM60, Disposable Medical Laryngeal Masks, MLM10, MLM15, MLM20, MLM25, MLM30, MLM40, MLM50, MLM60, Disposable Medical Laryngeal Masks, MLM10C, MLM15C, MLM20C, MLM25C, MLM30C, MLM40C, MLM50C, MLM60C, Disposable Medical Laryngeal Masks, PDLM10CS, PDLM15CS, PDLM20CS, PDLM25CS, PDLM30CS, PDLM40CS, PDLM50CS, Disposable Medical Laryngeal Masks, PDLM10S, PDLM15S, PDLM20S, PDLM25S, PDLM30S, PDLM40S, PDLM50S, Disposable Medical Laryngeal Masks, PMLM10CS, PMLM15CS, PMLM20CS, PMLM25CS, PMLM30CS, PMLM40CS, PMLM50CS, Exchange Assistant, Laryngoscope Blade for Single-Use, Size UED-A0/UED-A1/UED-A2/UED-A3/UED-A4/UED-MA1/UED-MC1/Ued-0/Ued-1/Ued-2/Ued-3/Ued-4 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Airway, Oropharyngeal, Anesthesiology | CAE | 1 | Manufacturer | accessdata.fda.gov |
| Bronchoscope (Flexible Or Rigid) | EOQ | 2 | Manufacturer | accessdata.fda.gov |
| Cart, Emergency, Cardiopulmonary (Excluding Equipment) | BZN | 1 | Manufacturer | accessdata.fda.gov |
| Laryngoscope, Non-Rigid | CAL | 1 | Manufacturer | accessdata.fda.gov |
| Laryngoscope, Rigid | CCW | 1 | Manufacturer | accessdata.fda.gov |
| Stylet, Tracheal Tube | BSR | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 11, 2025 | K251823 | UE BRONCHO Single-Use Bronchoscopes (EBS-380C); UE BRONCHO Single-Use Bronchoscopes (EBS-500C); UE BRONCHO Single-Use Bronchoscopes (EBS-600C); UE Display (UE-M10S) | EOQ | Substantially Equivalent | Zhejiang UE Medical Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Cart, Emergency, Cardiopulmonary (Excluding Equipment)
- All makers of Laryngoscope, Non-Rigid
- All makers of Airway, Oropharyngeal, Anesthesiology
- All makers of Laryngoscope, Rigid
- All makers of Stylet, Tracheal Tube
- All makers of Bronchoscope (Flexible Or Rigid)
Updated August 11, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.