Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004802740

FEI Number

3009809074

Entity Name

BioTissue Holdings Inc.

City/State/Country

Doral, FL, US

Establishment Address

8305 Nw 27th St, Suite 101, Doral, FL 33122, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BioTissue Holdings Inc. (Owner Number: 9067198)

Owner / Operator Contact Address

7300 Corporate Center Drive, Suite 700, Miami, FL 33126, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K032104

PMA Number

N/A

All Registered Proprietary Names

Prokera Slim Prokera Classic Prokera Plus Prokera Prokera Clear

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NQB	Conformer, Ophthalmic, Biological Tissue	Ophthalmic	Class 2	886.3130	2005-03-01

Official Correspondent

Alpesh Patel

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BioTissue Holdings Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004802740. Last updated year: 2026. Please use registration number 3004802740 when referencing this establishment in official correspondence.