N/A Ty-Ndeo-A1

by Tianyi Medical(Thailand) Limited

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number08859915300017 UDI-DI	Date1 Jan 2026Listed	StatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic Name: Haemodialysis blood tubing set, single-use
Model / Ref / Catalog: TY-NDEO-A1

Primary DI / UDI-DI: 08859915300017
510(k) Number: K251442
FDA Product Code: FJK
GMDN Term: Haemodialysis blood tubing set, single-use

Device Class: Class II
Regulation Number: 876.5820
GUDID distribution status: In Commercial Distribution

Other devices from Tianyi Medical(Thailand) Limited

N/A Ty-Ndeo-A2

Class II

Properties

Sterile
Single Use
Prescription Use
Lot / Batch Number
Expiration Date
Manufacturing Date

Other properties (8)

Implantable: No
Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Serial Number: No