SoftBank 25.6.2.0

by Scc Soft Computer

SoftBank 25.6.2.0 is a Class II device made by Scc Soft Computer, listed under FDA premarket submission BK200531 and listed in FDA GUDID since 13 Nov 2024 (UDI-DI 00810142371827), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) BK200531

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00810142371827 UDI-DI	Date13 Nov 2024Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k) from GUDID	NumberBK200531	Date—	StatusActive

Official records

AccessGUDID record UDI-DI 00810142371827

Across registries

2 registries list this device

FDA premarket submission BK200531 Active
FDA GUDID UDI-DI 00810142371827 listed 13 Nov 2024 Listed

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: SoftBank
Generic name: Blood bank information system application software
Model / reference: 25.6.2.0

Primary DI / UDI-DI: 00810142371827
FDA product code: MMH
GMDN term: Blood bank information system application software

Device class: Class II
Regulation number: 864.9165
GUDID distribution status: In Commercial Distribution

Other devices from Scc Soft Computer

See all devices from Scc Soft Computer →

Properties

Lot / batch number

Other properties (14, all answered No)