Box - 3C Patch® Kit 2

by Reapplix ApS

Box - 3C Patch® Kit 2 is a Class II device made by Reapplix ApS, listed under FDA premarket submission BK200471 and listed in FDA GUDID since 23 May 2019 (UDI-DI 05714188505503), 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) BK200471

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	Number05714188505503 UDI-DI	Date23 May 2019Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k) from GUDID	NumberBK200471	Date—	StatusActive

Official records

AccessGUDID record UDI-DI 05714188505503

Across registries

2 registries list this device

FDA premarket submission BK200471 Active
FDA GUDID UDI-DI 05714188505503 listed 23 May 2019 Listed

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Box - 3C Patch® Kit
Generic name: Haematological concentrate system preparation kit, platelet concentration
Model / reference: 2

Primary DI / UDI-DI: 05714188505503
FDA product code: PMQ
GMDN term: Haematological concentrate system preparation kit, platelet concentration

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

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Properties

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

Other properties (9, all answered No)