Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005555621

FEI Number

3005555621

Entity Name

CARDIA INNOVATION AB

City/State/Country

Bromma Stockholm, SE

Establishment Address

Gustavslundsvaegen 143, Bromma Stockholm SE-167 51, 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

CARDIA INNOVATION AB (Owner Number: 9076128)

Owner / Operator Contact Address

Gustavslundsvaegen 143, --, Bromma, SE-AB SE-167 51, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K112975

PMA Number

N/A

All Registered Proprietary Names

CarbonAid, CarbonMini

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2012-11-27

Official Correspondent

Sebastian Bauer

US Agent Details

Cherita James Business: Pro Pharma Group Email: cherita.james@propharmagroup.com Phone: (347) 9540624

Related Public Records

Same Entity

CARDIA INNOVATION AB

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K981334	Richard Wolf Medical Instruments Corp.	LAPARO CO2-PNEU (AND WITH VIDEO MONITORING)	1998-09-10

Similar Registrations

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1225798	ATC TECHNOLOGIES INC.	Wilmington, MA, US
9610612	AESCULAP AG	TUTTLINGEN, DONAU Baden-Wurttemberg, DE
1320894	CONMED CORPORATION	Utica, NY, US
3001556604	Novanta Medical GmbH	BERLIN, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005555621. Last updated year: 2026. Please use registration number 3005555621 when referencing this establishment in official correspondence.