Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003998872

FEI Number

3003998872

Entity Name

B&W TEK, INC.

City/State/Country

Newark, DE, US

Establishment Address

18 Shea Way Suite 103, Newark, DE 19713, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

B&W Tek, Inc. (Owner Number: 10082557)

Owner / Operator Contact Address

18 Shea Way Suite 103, Newark, DE 19713, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PHOTOFRIN 630 PDT Laser

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MVF	System, Laser, Photodynamic Therapy	Unknown	Class 3	N/A	2021-08-13

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

B&W Tek, 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 3003998872. Last updated year: 2026. Please use registration number 3003998872 when referencing this establishment in official correspondence.