REAPPLIX

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3014326253	3014326253	REAPPLIX	1	N	2026-01-01	Bregneroedvej 133A, st. th. Birkerod Sjalland DK 3460
3014635672	3014635672	Reapplix US	1	Y	2020-04-25	325 Miron Drive, Suite 140 Southlake TX US 76092

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
05714188021577	3CP™ Centrifuge - This label goes directly on the centrifuge. The 3CP Centrifuge is a table-top centrifuge that creates the output (i.e., PRP).	+4588168066	info@reapplix.com
05714188308005	3CP™ Centrifuge Kit - Kit that includes 3CP Centrifuge, power cord, external power supply, 3CP Counterbalance, bag with centrifuge tools, display protection shield, and 3CP Manual.	4588168066	info@reapplix.com

reapplix.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission
216759	1846178338	BK200471
216759	1023077634	BK170002
216759	1865207697	BK140211
216759	1462369321

PMN#

510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices

2017-04-04

Reapplix Aps

510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices

2016-02-24

Reapplix Aps

GUDID#

3CP™ Centrifuge - This label goes directly on the centrifuge. The 3CP Centrifuge is a table-top centrifuge that creates the output (i.e., PRP).

Reapplix ApS

2018-07-19

3C Patch® Device - Extra Component Set - This is the outer label for the box that contains 20 3C Patch Deviceds and the IFU.

Reapplix ApS

2019-05-23

Box - 3C Patch® Kit - This is the outer label for the box that includes 12 3C Patch® Kits and the IFU.

Reapplix ApS

2019-05-23

4 x (21G Needle + 3C Patch® Needle Holder) - This is the retail bag label for the retail bag, which contains 6 venipuncture needle sets (commercially available) and 6 3C Patch Needle Holders.

Reapplix ApS

2019-05-23

3C Patch® Kit - Kit that includes 3C Patch Device, 3C Patch Needle Holder, Venipuncture Needle Set (commercially available), Skin Preparation Alcohol Swab (commercially available), Post-Sampling Adhesive Bandage (band aid) (commercially available), and Primary Wound Cover Dressing (commercially available).

Reapplix ApS

2019-05-23

3C Patch® Device - Holds the blood at collection and during processing in the centrifuge.

Reapplix ApS

2019-05-23

3C Patch® Needle Holder - Used to attach and hold the 3C Patch Device with the supplied venipuncture set.

Reapplix ApS

2019-05-23

3CP™ Centrifuge Kit - Kit that includes 3CP Centrifuge, power cord, external power supply, 3CP Counterbalance, bag with centrifuge tools, display protection shield, and 3CP Manual.

Reapplix ApS

2019-05-23

3CP™ Counterbalance - Used with 3CP Centrifuge to counterbalance weight of 3C Patch Device(s).

Reapplix ApS

2019-05-23

3C Patch® Device - Extra Component Set - This is the outer label for the box that contains 20 3C Patch Deviceds and the IFU.

Reapplix ApS

2019-01-09

3C Patch® Kit - Box - This is the outer label for the box that includes 12 3C Patch Kits and the IFU.

Reapplix ApS

2018-07-19

Venipuncture Needle and 3C Patch® Needle Holder - Extra Component Set - This is the outer label for the box that contains 20 venipuncture needle sets (commercially available), 20 3C Patch Needle Holder, and the IFU.

Reapplix ApS

2019-01-09

3C Patch® Kit - Kit that includes 3C Patch Device, 3C Patch Needle Holder, Venipuncture Needle Set (commercially available), Skin Preparation Alcohol Swab (commercially available), Post-Sampling Adhesive Bandage (band aid) (commercially available), and Primary Wound Cover Dressing (commercially available).

Reapplix ApS

2018-07-19

3C Patch® Device - Holds the blood at collection and during processing in the centrifuge.

Reapplix ApS

2018-07-19

3C Patch® Needle Holder - Used to attach and hold the 3C Patch Device with the supplied venipuncture set.

Reapplix ApS

2018-07-19

3CP™ Centrifuge Kit - Kit that includes 3CP Centrifuge, power cord, external power supply, 3CP Counterbalance, bag with centrifuge tools, display protection shield, and 3CP Manual.

Reapplix ApS

2018-07-19

3CP™ Counterbalance - Used with 3CP Centrifuge to counterbalance weight of 3C Patch Device(s).

Reapplix ApS

2018-07-19

3CP™ Centrifuge Kit - Kit that includes 3CP Centrifuge, power cord, external power supply, 3CP Counterbalance, bag with centrifuge tools, display protection shield, and 3CP Manual.

Reapplix ApS

2019-04-03