Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038613128

FEI Number

3038613128

Entity Name

BLUE MEDICAL BV

City/State/Country

Zaandam Noord-Holland, NL

Establishment Address

Sluispolderweg 79, Zaandam Noord-Holland 1505HJ, NL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Blue Medical BV (Owner Number: 10093583)

Owner / Operator Contact Address

Sluispolderweg 79, Zaandam, NL-NH 1505HJ, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LXZ	Guard, Instrument	General, Plastic Surgery	Class 1	878.4800	2025-06-06

Official Correspondent

No official correspondent registered.

US Agent Details

Rosanna Lee Business: Simcon International LLC Email: rlee@simconintl.com Phone: (847) 9492290

Related Public Records

Same Entity

Blue Medical BV

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 3038613128. Last updated year: 2026. Please use registration number 3038613128 when referencing this establishment in official correspondence.