Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027454635

FEI Number

3027454635

Entity Name

LiNA Medical ApS

City/State/Country

Naerum Hovedstaden, DK

Establishment Address

Naerum Hovedgade 10B, Naerum Hovedstaden 2850, DK

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

LINA MEDICAL APS (Owner Number: 9044000)

Owner / Operator Contact Address

FORMERVANGEN 5, --, GLOSTRUP, DK-84 2600, DK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

LiNA SeaStar, SS model (4000-S-SS) LiNA CystoVu HD Biopsy Forceps (CYV-FCP-5) Skater Fix (8199) LiNA CystoVu HD Grasper (CYV-GRA-5)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HIN	Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)	Obstetrics/Gynecology	Class 2	884.4150	2013-07-29
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2011-05-05
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2018-01-26
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2006-12-29
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2020-08-20
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2020-08-20
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2020-08-20
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2025-04-09
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2006-12-29
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2006-12-29
PTS	Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt	Gastroenterology, Urology	Class 2	876.1500	2025-04-09
NWW	Hysteroscope Accessories	Obstetrics/Gynecology	Class 1	884.1690	2018-04-09

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

LINA MEDICAL APS

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007699067	LiNA Medical Polska sp. z o.o	Tarnowo Podgorne Wielkopolskie, PL

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K936071	Smith & Nephew Dyonics, Inc.	SMITH & NEPHEW DYONICS INC. ELECTRONIC ENDOSCOPE	1994-08-19
K953574	American Hydro-Surgical Instruments, Inc.	NEZHAT-DORSEY HYDRO-DISSECTION UNIVERSAL BAG SQUEEZER	1995-09-29
K935716	KARL STORZ Endoscopy-America, Inc.	KARL STORZ FIXED MAGNIFICATION TELESCOPE/KS VARIABLE MAGNIFICATION TELESCOPE	1995-11-16
K922626	Andronic Devices, Ltd.	ADEPT INSTRUMENT POSITIONING ACCESSORY	1992-10-19
K820290	The Anspach Effort, Inc.	SELF RETAINING RETRACTOR FOR HAND SURG	1982-03-05

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0023-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF: C0604 15 x 100mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0024-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF:C0605 15x100mm Threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0025-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF: C0606 15x150mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0026-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF: C0607 15x150mm Threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.

Similar Registrations

Registration Number	Establishment Name	Location
2244478	LYNX Medical NJ	Franklin, NJ, US
3010202439	Karl Storz Endoscopy-America, Inc.	El Segundo, CA, US
8030607	Industrias Apson S.A de C.V	AGUA PRIETA Sonora, MX
1421101	Instrumed International Inc dba Avalign German Specialty Instruments	SCHAUMBURG, IL, US
3007699067	LiNA Medical Polska sp. z o.o	Tarnowo Podgorne Wielkopolskie, PL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027454635. Last updated year: 2026. Please use registration number 3027454635 when referencing this establishment in official correspondence.