← Back to catalogue

RegenPlasma/RegenKit-Woud Gel-2

FDA UDI

Class II (US FDA UDI)

by Regen Lab Sa

Identity

Trade Name
RegenPlasma/RegenKit-Woud Gel-2 FDA UDI
Generic Name
Haematological concentrate system preparation kit, platelet concentration FDA UDI
Device Name
The RegenKit®-Wound Gel-2 contains 2 RegenWound PRP Tubes and 1 RegenWound ATS Tube. INTENDED USE / INDICATIONS FOR USE RegenKit®-Wound Gel-2 is designed to be used at point-of-care for the safe and rapid preparation of platelet-rich plasma (PRP) gel (RegenWound Gel) from a small sample of a patient’s own peripheral blood. Under the supervision of a healthcare professional, the RegenWound Gel is topically applied for the management of exuding cutaneous wounds, such as leg ulcers, pressure ulcers and diabetic ulcers, and mechanically or surgically debrided wounds. FDA UDI
Model / Reference
RK-WG-2 FDA UDI
Description
The RegenKit®-Wound Gel-2 contains 2 RegenWound PRP Tubes and 1 RegenWound ATS Tube. INTENDED USE / INDICATIONS FOR USE RegenKit®-Wound Gel-2 is designed to be used at point-of-care for the safe and rapid preparation of platelet-rich plasma (PRP) gel (RegenWound Gel) from a small sample of a patient’s own peripheral blood. Under the supervision of a healthcare professional, the RegenWound Gel is topically applied for the management of exuding cutaneous wounds, such as leg ulcers, pressure ulcers and diabetic ulcers, and mechanically or surgically debrided wounds. FDA UDI

Identifiers

Primary DI / UDI-DI
07640138981616 FDA UDI
FDA Product Code
PMQ FDA UDI
GMDN Term
Haematological concentrate system preparation kit, platelet concentration FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.9245 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Haematological concentrate system preparation kit, platelet concentration

RegenPlasma/RegenKit-Woud Gel-2 by Regen Lab Sa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Haematological concentrate system preparation kit, platelet concentration.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Regen Lab Sa

Sources (1)

  • FDA UDI 9300c9f3-5f54-4b54-b792-7935d2fac1eb 34 fields · synced May 29, 2026