CLUNAS AG

FDA Device Registration & Listing · Tarnowo Podgorne Wielkopolskie, PL · Registration 3019569846

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3019569846
FEI Number
3019569846
Entity Name
CLUNAS AG
City/State/Country
Tarnowo Podgorne Wielkopolskie, PL
Establishment Address
ul. Rolna 4B, Sady, Tarnowo Podgorne Wielkopolskie 62-080, PL
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Clunas AG (Owner Number: 10085874)
Owner / Operator Contact Address
ul. Rolna 4B, Sady, Tarnowo Podgórne, PL-30 62-080, PL
Initial Importer Flag
N
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
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2022-12-02
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2022-11-18
FYD Apparatus, Exhaust, Surgical General, Plastic Surgery Class 2 878.5070 2022-12-02
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2022-08-26

Official Correspondent

Anna Michalska

US Agent Details

Nadege Boursiqout Business: LiNA Medical INC Email: nadege@linamed.com Phone: (770) 2186801

Related Public Records

Same Entity

Clunas AG
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
K970809 Somnus Medical Technologies, Inc. BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL 1997-06-18
K222793 C.R. Bard, Inc. WavelinQ™ Generator 2022-10-17
K002257 Tecno Instruments (Pvt.) , Ltd. TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100 2000-10-19
K193591 Bowa-Electronics GmbH & Co. KG ARC 400 2020-04-02
K192128 Sutter Medizintechnik GmbH Sutter Arrowtip Monopolar Electrodes 2019-10-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0031-06 Rita Medical Systems 2
Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

Similar Registrations

Registration Number Establishment Name Location
3007353760 ENERGIST LIMITED Swansea, GB
3005064998 RDI INC. Mount Kisco, NY, US
3020623326 TRIWORKS GROUP S.R.L. Palata Campobasso, IT
3012616488 BRERA MEDICAL INCORPORATED Northborough, MA, US
3012940012 Sutter Medical Technologies USA Inc. Alpharetta, GA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3019569846. Last updated year: 2026. Please use registration number 3019569846 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.