Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004008703

FEI Number

3004008703

Entity Name

BOULE MEDICAL AB

City/State/Country

Spanga Stockholm, SE

Establishment Address

Fagerstagatan 7, Spanga Stockholm 163 53, SE

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Boule Diagnostics AB (Owner Number: 9034165)

Owner / Operator Contact Address

Fagerstagatan 7, Spanga, SE-NOTA SE-163 53, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

501-475 Quintus 5-Part Lyse Medonic M51-L1 Lyse 501-464 Medonic M-Series Lyse 501-466 Swelab Alfa Lyse Swelab Lumi-L2 Lyse Medonic M51-L2 Lyse Swelab Lumi-L1 Lyse 501-292 Quintus 5-Part Diluent Cell-Dyn Emerald Diluent 501-202 CDS Hematology Diluent Medonic M51-D Diluent 501-057 CDS Hematology Diluent 501-069 CDS HEMATOLOGY DILUENT 501-465 Swelab Alfa Diluent 501-201 CDS Hematology Diluent 501-212 Medonic M-Series Diluent 501-052 CDS Hematology Diluent 501-056 CDS Hematology Diluent 501-081 CDS Diluent Sheath Swelab Lumi-D Diluent 501-128 HEMATOLOGY DILUENT 501-133 CDS KX21 Hematology Diluent 501-067 CDS HEMATOLOGY DILUENT 501-208 Swelab Alfa Diluent 501-463 Medonic M-Series Diluent 501-003 HEMATOLOGY DILUENT 501-476 Quintus 5-Part Diluent 501-074 Enzymatic Cleaner Concentrate 501-477 Quintus 5-Part Stopper Cell-Dyn Emerald Cleaner 501-002 ENZYMATIC CLEANER 501-205 CDS Rinse Solution 501-350 Quintus 5-Part Stopper 501-036 Boule Cleaning Kit 501-029 Ac.T Cleaner and Shutdown Solution 501-204 CDS Rinse Solution 501-073 CDS DETERGENT REAGENT 501-064 CDS DETERGENT REAGENT 501-032 ENZYMATIC CLEANER 501-063 ENZYMATIC CLEANER CONCENTRATE Boule EasyCleaner 501-066 CDS DETERGENT REAGENT Boule, MPA Micro Pipettes Plastic

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GGK	Products, Red-Cell Lysing Products	Hematology	Class 1	864.8540	1999-06-04
GIF	Diluent, Blood Cell	Hematology	Class 1	864.8200	2013-02-13
JCB	Detergent	Pathology	Class 1	864.4010	2015-11-17
GIO	Tube, Collection, Capillary Blood	Hematology	Class 1	864.6150	2008-10-23

Official Correspondent

No official correspondent registered.

US Agent Details

Junelle Goldson Business: Clinical Diagnostics Solutions Email: junelle.goldson@boule.com Phone: (954) 4539139

Related Public Records

Same Entity

Boule Diagnostics AB

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1064130	CLINICAL DIAGNOSTIC SOLUTIONS, INC.	PLANTATION, FL, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004008703. Last updated year: 2026. Please use registration number 3004008703 when referencing this establishment in official correspondence.