Tropocells 521254US

by Estar Technologies Ltd

Tropocells 521254US is a haematological concentrate system preparation kit (FDA Class II; FDA product code ORG, Platelet And Plasma Separator For Bone Graft Handling) made by Estar Technologies Ltd, listed under FDA premarket submission BK110035 and listed in FDA GUDID since 20 Oct 2016 (UDI-DI 07290015874359), active as of 23 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 23 Oct 2026

Documents

510(k) BK110035

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number07290015874359 UDI-DI	Date20 Oct 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k) from GUDID	NumberBK110035	Date—	StatusActive

Official records

AccessGUDID record UDI-DI 07290015874359

Across registries

2 registries list this device

FDA premarket submission BK110035 Active
FDA GUDID UDI-DI 07290015874359 listed 20 Oct 2016 Listed

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Tropocells
Generic name: Haematological concentrate system preparation kit, platelet concentration
Model / Ref / Catalog: 521254US

Primary DI / UDI-DI: 07290015874359
FDA product code: ORG
GMDN term: Haematological concentrate system preparation kit, platelet concentration

Device class: Class II
Regulation number: 864.9245
GUDID distribution status: In Commercial Distribution

Other devices from Estar Technologies Ltd

Tropocells® PRP

Class I
Tropocells® PRP

Class IIb
Tropocells® PRP

Class IIa
Tropocells® PRP

Class IIa

See all devices from Estar Technologies Ltd →

Properties

Supplied sterile
Single use
Prescription use
Convenience kit
Lot / batch number
Expiration date

Other properties (9, all answered No)