Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006845489

FEI Number

3006845489

Entity Name

ONDINE RESEARCH LABORATORIES/ONDINE BIOMEDICAL INC. (US)

City/State/Country

Bothell, WA, US

Establishment Address

19017 120TH AVE NE STE 102, Bothell, WA 98011, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

Ondine Biomedical Inc. (Owner Number: 10049666)

Owner / Operator Contact Address

19017 120Th Ave NE, Ste. 102, Bothell, WA 98011, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MRSAid Nasal Light Illuminator Assembly (NLIA) Steriwave nasal light Illuminator Assembly (NLIA) Periowave Light Diffusing Tip Steriwave SW4000 Light Source Periowave 1ml photosensitizer Champion Debrider Sinus Irrigation Catheter SurgENT Sinus Irrigation Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EQH	Source, Carrier, Fiberoptic Light	Ear, Nose, Throat	Class 1	874.4350	2015-07-07
EQH	Source, Carrier, Fiberoptic Light	Ear, Nose, Throat	Class 1	874.4350	2018-05-07
MVF	System, Laser, Photodynamic Therapy	Unknown	Class 3	N/A	2020-06-16
EIC	Syringe, Periodontic, Endodontic, Irrigating	Dental	Class 1	872.4565	2018-05-07
GBA	Catheter, Balloon Type	General, Plastic Surgery	Class 1	878.4200	2017-09-13

Official Correspondent

Roger Andersen

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Ondine Biomedical 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 3006845489. Last updated year: 2026. Please use registration number 3006845489 when referencing this establishment in official correspondence.