Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021091077

FEI Number

3021091077

Entity Name

BLUEBIRD MEDICAL AB

City/State/Country

Fjaras Halland, SE

Establishment Address

Ormvraksvagen 46, Fjaras Halland 43974, SE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Bluebird Medical AB (Owner Number: 10095156)

Owner / Operator Contact Address

Ormvraksvagen 46, Fjaras, SE-N 43974, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Bluebird Medical Replacement Clamp

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FKC	Clamp, Cannula	Gastroenterology, Urology	Class 1	876.5540	2026-06-07

Official Correspondent

No official correspondent registered.

US Agent Details

Scott Bednar Business: QA/RA CONSULTING GROUP, INC. Email: sbednar@qaraconsultinggroup.com Phone: (412) 4188066

Related Public Records

Same Entity

Bluebird Medical AB

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 3021091077. Last updated year: 2026. Please use registration number 3021091077 when referencing this establishment in official correspondence.