Device filings

Class-I medical device — filed

Production and operation filings for the cell-preparation line are on record with the local administration. Certificate below.

Class-I medical device filing certificate
Patents

Own inventions, published

The NuoqTFF™ 1.0 line and supporting devices are covered by our own patent family — including CN112877190A, a storage-transport umbilical cord blood filtration device, among high-value invention filings.

Patent publication CN112877190A first page
Standards

We draft the rules we ship under

Contributor to the national guideline on exosome particle-size and concentration measurement, and drafter of group standards covering EV nebulized-inhalation therapy, dental-pulp cell preparation and storage, and immune-cell isolation and storage.

Group standard: EV nebulized inhalation therapy Group standard: dental pulp stem cell preparation Group standard: immune cell isolation and storage
Third-party testing

Independent lab verification

Exosome product tested by Zhongke Ruiji (Jiaxing) — an independent third-party laboratory. Full virology panel negative (HBV-DNA, HIV-I/II RNA) plus complete quality characterization.

Third-party exosome testing report
Patent certificate

Invention patent granted

Patent No. ZL 2021 1 0013641.0 — "Umbilical cord blood filtration device for storage and transport" (Certificate No. 5230932). Patent holders include our own team members. Granted June 2022, valid 20 years.

Invention patent certificate
Business registration

Registered and compliant

Founded June 2021 with RMB 10 million registered capital. Business scope explicitly covers cell technology R&D and technical services.

Business license