FDA Registration
FDA Registration & Compliance
OLERN Medical is operated by ZHENG HE CROSS-BORDER LIMITED, a registered
Foreign Exporter with the U.S. Food and Drug Administration.
Trust matters when you are purchasing medical equipment. That is why we want our customers to know that every product category we sell is covered by an active U.S. FDA registration held by our operating company.
You can independently verify our registration on the official FDA database at any time using the registration number below.
Registration Information
| Registered Entity | ZHENG HE CROSS-BORDER LIMITED |
| Registered Address | Room Q, Unit 608, 6/F., Metro Loft, 38 Kwai Hei Street, Kwai Chung, N.T., Hong Kong, 999077 |
| FDA Registration Number | 3017637606 |
| Owner/Operator Number | 10090871 |
| Registration Role | Foreign Exporter |
| Fiscal Year | 2026 |
Registered Product Categories
The following product categories sold on this website are covered under our FDA registration:
| Listing No. | Product Code | Proper Name |
|---|---|---|
| D536859 | FNL | Electric Hospital Bed |
| D536860 | FNJ | Electric Nursing Bed |
| D536861 | BWN | Medical Cart, Emergency Trolley, Instrument Trolley |
| D536862 | INW | Examining Table, Massage Table |
| D536863 | INM | Medical Chairs, Medical Recliner |
| D592682 | JRM | Medical Pharmacy, Refrigerator Medical, Refrigerator, Lab Refrigerator |
How to Independently Verify Our Registration
- Visit the FDA's official Establishment Registration & Device Listing database: accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm
- Enter our Registration Number 3017637606 in the search field.
- Confirm that the registered entity name matches ZHENG HE CROSS-BORDER LIMITED.
Important note about FDA registration: FDA Establishment Registration and Device Listing means our facility and the categories of devices we export are on file with the U.S. FDA, as required by 21 CFR Part 807. This is a regulatory requirement for foreign medical device exporters. FDA registration does not constitute FDA approval or endorsement of any specific product. Class I medical devices in the categories we list are generally exempt from premarket notification (510(k)) requirements.
Questions About Compliance?
If you have questions about our regulatory status, registration coverage, or product documentation, please contact our customer service team:
Email: support@olernmedical.com
Hours: Monday – Friday, 9:00 AM – 6:00 PM EST