Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3031563141

FEI Number

3031563141

Entity Name

GETINGE AB

City/State/Country

POZNAN Wielkopolskie, PL

Establishment Address

KOPANINA 30A, POZNAN Wielkopolskie 60-105, PL

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Getinge AB (Owner Number: 10090886)

Owner / Operator Contact Address

Kopanina 30A, Poznan, PL-30 PL 60-105, PL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Getinge 800HC-E Series Steam Sterilizer 1180 52A0 Multimodality Headrest, Fixed Rigid Head Rest 1002.82A0 Transmobile TT, Transmobile TT-M ALPHACLASSIC MAGNUS ALPHAMAQUET OTESUS ALPHASTAR ALPHAMAXX MAQUET OPERATING TABLES CORIN ORTHOSTAR BETASTAR YUNO II MEERA, MEERA ST, MEERA CL YUNO ALPHASTAR PRO MAQUET OPERATING TABLES BETACLASSIC X'TEN (X10) Hanaulux Blue 80 Hosp Model 733HC-E Getinge Aquadis PCU Hanaulux Blue 30 80 Gel pads MAQUET STERIGRIP PowerLED 500 Rolite Power LED POWERLED PowerLED 300 PowerLED 700 Model 633 AXCEL VOLISTA STANDOP II VOLISTA ACCESS VOLISTA ACCESS II VOLISTA STANDOP VOLISTA 1180.12F0 Multimodality Transfer Table Top 1180.71C0 Transfer Board Getinge 400HC-E/500HC-E Series Steam Sterilizer YUNO Femur Hook MAQUET EQUIPMENT SATELITE MEDIA HD GSS610N21 Series Steam Sterilizer GSS67N Steam Sterilizer MAQUET MAGNUS carbon-fibre table top (1180.16XX; T285.7000) TRIMANO Fortis TRIMANO YUNO II Accessories to YUNO; ALPHAMAXX; ALPHASTAR PRO; MAGNUS; ALPHAMAQUET; BETASTAR; ALPHACLASSIC; OTESUS; MEERA Maquet Rolite Maquet PowerLED II Maquet EZEA GSS610N10; GSS61014, and GSS61015 Steam Sterilizers Hanaulux 2000 YUNO II ALPHASTAR; YUNO; ALPHAMAXX; ALPHASTAR PRO; MAGNUS; ALPHAMAQUET; BETASTAR; ALPHACLASSIC; OTESUS; MEERA Accessory to MAQUET OR Tables, Product no. 1005.XX ORCHIDE 3D ORCHIDE Maquet Orchide ORCHIS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2024-05-29
IWY	Holder, Head, Radiographic	Radiology	Class 1	892.1920	2024-08-05
FPO	Stretcher, Wheeled	General Hospital	Class 2	880.6910	2024-08-05
FQO	Table, Operating-Room, Ac-Powered	General, Plastic Surgery	Class 1	878.4960	2024-08-05
FSE	Table, Operating-Room, Manual	General, Plastic Surgery	Class 1	878.4950	2024-08-05
FSY	Light, Surgical, Ceiling Mounted	General, Plastic Surgery	Class 2	878.4580	2024-08-05
FSS	Light, Surgical, Floor Standing	General, Plastic Surgery	Class 2	878.4580	2024-08-05
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2024-05-28
FLG	Cleaner, Ultrasonic, Medical Instrument	General Hospital	Class 1	880.6150	2024-12-16
FSY	Light, Surgical, Ceiling Mounted	General, Plastic Surgery	Class 2	878.4580	2024-08-05
FSS	Light, Surgical, Floor Standing	General, Plastic Surgery	Class 2	878.4580	2024-08-05
LWG	Surgical Table Cushion	General, Plastic Surgery	Class 1	878.4950	2024-12-16
FTA	Light, Surgical, Accessories	General, Plastic Surgery	Class 2	878.4580	2024-12-16
FSY	Light, Surgical, Ceiling Mounted	General, Plastic Surgery	Class 2	878.4580	2024-08-05
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2024-05-28
FSY	Light, Surgical, Ceiling Mounted	General, Plastic Surgery	Class 2	878.4580	2024-08-05
FSY	Light, Surgical, Ceiling Mounted	General, Plastic Surgery	Class 2	878.4580	2024-08-05
FTD	Lamp, Surgical	General, Plastic Surgery	Class 2	878.4580	2024-08-05
IXQ	Table, Radiographic, Stationary Top	Radiology	Class 2	892.1980	2024-08-05
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2024-05-29
KIK	Hook, Bone	General, Plastic Surgery	Class 1	878.4800	2024-08-05
FXR	Holder, Camera, Surgical	General, Plastic Surgery	Class 1	878.4160	2024-08-05
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2024-12-16
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2024-08-05
KXJ	Table, Radiologic	Radiology	Class 2	892.1980	2024-08-05
BWN	Table And Attachments, Operating-Room	General, Plastic Surgery	Class 1	878.4950	2024-08-05
FSS	Light, Surgical, Floor Standing	General, Plastic Surgery	Class 2	878.4580	2024-12-16
FTD	Lamp, Surgical	General, Plastic Surgery	Class 2	878.4580	2024-12-16
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2024-08-05
FTD	Lamp, Surgical	General, Plastic Surgery	Class 2	878.4580	2024-08-05
JEA	Table, Surgical With Orthopedic Accessories, Ac-Powered	General, Plastic Surgery	Class 1	878.4960	2024-08-05
HBM	Headrest, Neurosurgical	Neurology	Class 1	882.4440	2024-08-05
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2024-08-05

Official Correspondent

No official correspondent registered.

US Agent Details

Emily Valerio Email: emily.valerio@getinge.com Phone: (862) 2215193

Related Public Records

Same Entity

Getinge 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
K021223	Sauter AG	BELIMED STEAM STERILIZER, MODEL TOP 5000	2002-06-26
K050263	M.O. Com S.R.L.	MILLENNIUM SERIES, INCLUDING MILLENNIUM B, B+, B2 AND BU	2006-11-21
K780666	Castle Co.	DAYSTAR SELECTRA & SELECTRA/ORBITER	1978-04-27
K812396	Northwest Surgical Concepts, Inc.	ARTHRO-PREP REST	1981-11-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0023-05	Stryker Medical	2	Stryker brand Rugged EZ-Pro R4 Ambulance Cot, model 6092.
Z-0036-2024	Getinge Usa Sales Inc	1	Meera Mobile Operating Table-to support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment. Model Number: 7200.01F2
Z-0028-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800091, Sterile, LD0692 - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0029-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800401, Sterile, GS0470 - Lap Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0030-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800407, Sterile, OR0476 - Ortho Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROI, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

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8030087	TUTTNAUER LTD.	BEIT SHEMESH Jerusalem, IL
3022516928	DENT4YOU AG	Heerbrugg Sankt Gallen, CH
3012068831	Getinge IC Production Poland sp. z o.o.	Plewiska Wielkopolskie, PL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031563141. Last updated year: 2026. Please use registration number 3031563141 when referencing this establishment in official correspondence.