Certificates & Quality
Regulatory documents for NAGY products, issued to the manufacturer, Nagy Oral Technology Qinhuangdao Co., Ltd. Copies are available on request.
US FDA 510(k) Premarket Notification
| Status | Cleared |
|---|---|
| Number | K253052 |
| Product | Fluoride Varnish (Type A, Type C) |
| Indication | To relieve dental hypersensitivity |
| Holder | Nagy Oral Technology Qinhuangdao Co., Ltd. |
ISO 13485:2016 Quality Management System
| Certificate | CN26/00005896 |
|---|---|
| Issued by | SGS United Kingdom Ltd |
| Valid until | 9 August 2029 |
| Holder | Nagy Oral Technology Qinhuangdao Co., Ltd. |
Certificate for Exportation of Medical Products
| Number | MDHE2026000121 |
|---|---|
| Issued by | Hebei Medical Products Administration |
| Valid until | 8 September 2029 |
| Holder | Nagy Oral Technology Qinhuangdao Co., Ltd. |
Who makes NAGY products
Nagy Oral Technology Qinhuangdao Co., Ltd.
An Aidite Group company.
No. 9 Dushan Road, Economic & Technological Development Zone, Qinhuangdao, Hebei, China
NAGY Overseas Sales Department is the factory's official overseas sales team. Certificates list the manufacturer; OEM customers act as importer of record. Batch Certificates of Analysis (COA) are available for every product.
From order to shipment
Batch COA
Factory test report supplied with each batch.
Shelf life
3 years for fluoride varnish, room temperature, dry storage.
Samples
Free samples, freight collect, dispatched in 3–5 days.
Export documents
Commercial invoice, packing list and customs declaration; FOB or FCA.
Samples, specifications and private-label quotes
Tell us your market, product and quantity. Free samples available (freight collect), shipped in 3–5 days.