Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3020157853

FEI Number

3020157853

Entity Name

GULDMANN-UKRAINE LTD

City/State/Country

Lviv L'vivs'ka Oblast', UA

Establishment Address

Shevchenko Str. 73, Kulykiv L'Viv Region, Lviv L'vivs'ka Oblast' 80362, UA

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

V. GULDMANN A/S (Owner Number: 9027662)

Owner / Operator Contact Address

14401 McCormick Drive, Unit A, Tampa, FL 33626, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Basic Comfort High, Poly, S Disposable High II, XS Disposable Comfort High, S Custom Amputee, M Basic High, Net, XL Basic Comfort High, Net, XS Repositioning Sling, Spacer Sit-On II, L Dispo. Micro Plus XXL, Box of 5 slings Sit-On, XS Basic High, Net, L Basic High, Poly, Kid 10-14 Dispo. Gait Trainer, XL Basic High, Poly, Kid 6-10 Active Trainer, S Disposable High II, L Repositioning Sling, Spacer, 6 loops Disposable Multi Support Sling Basic High, Poly, L Sit-On Comfort High, XS Sit-On, XL Sit-On II, XL Basic High Bariatric, 5XL Dispo. Gait Trainer, XXL Custom Amputee, XS Active Micro, Poly, S Sit-On, Kid 4-6 Basic Basic, Net, XL Repositioning Sling, Bariatric Box 5 Sit-On Comfort High, XXL Sit-On High, Kid 6-10 Basic High, Net, S Disposable Leg Sling II Sit-On Comfort, XS Basic Basic, Net, XXL Repositioning Sling, Short, Box 10 Active Micro Plus, Kids 4-6 Basic Hammock, L Sit-On II, Kid 4-6 Sit-On High, L Standing Sling, L Sit-On High II, XL Active Micro Plus, M Disposable High, M Twin Turner, Regular Disposable Comfort High, M Extension strap, 30 cm Dispo. Micro Plus XL, Box of 5 slings Basic Basic, Poly, XS Basic Comfort High, Poly, XL Cross hanger - 500kg Basic Basic, Poly, Kid 10-14 Basic Hammock, S Basic Comfort High, Poly, XS Active Micro, Poly, XXL Standing Sling, XXL Active Vest, Kid 4-6 Basic Shell, XL Sit-On II, XS Active Micro Plus, Kid 6-10 Disposable Comfort High, L Basic High, Poly, XXL Sit-On Comfort High, Kid 4-6 Sit-On, L Active Micro, Poly, L Basic Comfort High, Net, XXL Cross hanger - 400kg Disposable High II, M Disposable Comfort High, XL Sit-On Comfort, S Sit-On, M Dispo. Gait Trainer, L Basic High, Net, M Sit-On High II, XXXL Basic Basic, Net, L Sit-On High II, S Modified Sling, Poly Active Trainer, Kid 10-14 Active Trainer, L Basic Basic, Poly, L Lifting hanger MEDIUM Active Micro Plus, S Active Vest, Kid 10-16 Repositioning Sling, Poly Sit-On Comfort High Hygi, S Active Micro, Poly, M Sit-On, S Basic High, Net, Kid 10-14 Pannus Support Custom Amputee, L Sit-On Comfort High, XXXL Turner Disposable High, Bariatric, L/XL Standing Shell Vest, XS Disposable Comfort High, XXL Basic Shell, XS Basic Basic, Poly, XXL Active Micro Plus, Kid 10-14 Standing Sling, S/M Basic Basic, Net, Kid 10-14 Active Trainer, M Disposable High II, XL Basic Low, Poly, XL Basic Basic, Net, M Basic High, Poly, S Sit-On II, Kid 6-10 Basic Low, Net, S Basic Low, Poly, S Sit-On Comfort, M Horizontal lifting support, stepless weight adjustment Horizontal Sling, Standard Sit-On Comfort High, S Gait Trainer, XXL Sit-On High, S Leg Sling Box of 10 pcs Basic High, Poly, M Lifting hanger SMALL Basic Low, Poly, L Sit-On Comfort High, Kid 6-10 Basic Basic, Poly, M Active Micro Plus, XXL Standing Sling, XL Sit-On Comfort, L Basic High, Net, XXL Standing Shell Vest, Kid 6-10 Gait Trainer, L Sit-On High II, Kid 6-10 Basic Low, Poly, M Standing Shell Vest, Kid 10-16 Sit-On Comfort High, M Basic Low, Net, L Active Trainer, Kid 6-10 Sit-On High II, M Active Micro Plus, L Gait Trainer, M Horizontal lifter, Foldable, 2 strap version Basic Basic, Poly, S Sit-On, Kid 6-10 Sit-On High II, L Basic High, Net, Kid 6-10 Disposable High II, S Disposable Repo w. Smart Loops Sit-On Comfort, Kid 4-6 Twin Turner, Large Basic Comfort High, Net, XL Basic Comfort High, Poly, M Basic High Net, Kid 4-6 Custom Amputee, XL Basic Low, Poly, XS Gait Trainer, S Basic Basic, Poly, Kid 6-10 OR Sling, Poly, L Basic Shell, S Disposable Twin Turner II, Regular Sit-On Comfort, Kid 6-10 Disposable High II, Kids 6-10 Gait Trainer, XL Basic Low, Net, M Active Trainer, XL Basic Basic, Poly, XL Basic Comfort High, Net, L Dispo. Gait Trainer, M Disposable Comfort High, XS OR Sling, Poly, M Sit-On High, M Basic Hammock, XS Lifting hanger X-SMALL Dispo. Gait Trainer, S Basic High, Net, XS Multi Support Sling Disposable High, XXL Basic High, Poly, XL Repositioning Sling Box 10 Sit-On High II, XS Disposable Twin Turner II, Large Disposable High, L Disposable High, XL Modified Sling, Net Basic Basic, Net, S Basic Basic, Poly, Kid 4-6 Basic Low, Net, XXL Dispo. Micro Plus M, Box of 5 slings Horizontal lifter, Foldable, 1 strap version Basic High, Poly, XS Sit-On High II, Kid 4-6 Disposable Horizontal, Standard Dispo. Micro Plus S, Box of 5 slings Basic Low, Poly, XXL Dispo. Micro Plus XS, Box of 5 slings Basic Basic, Net, Kid 4-6 Basic Basic, Net, Kid 6-10 Sit-On High, XL Sit-On Comfort, XL Active Trainer, XS Basic Shell, M Basic Comfort High, Net, M Active Micro Plus, XS Dispo. Micro Plus L, Box of 5 slings Repositioning Sling, Grey net Box 10 Basic Basic, Poly, XXXL Repositioning Sling, TENCEL Box 10 Disposable High II, XXL Basic Low, Net, XS Sit-On Comfort High, L H-hanger Basic Comfort High, Net, S Basic High Bariatric, 4XL Active Trainer, XXL Sit-On Comfort High Hygi, XS Disposable High, Bariatric, XXL/XXXL Disposable High, Bariatric, XL/XXL Basic Comfort High, Poly, L Connecting bar + cross hanger 500kg Custom Amputee, S Sit-On Comfort High Hygi, L Sit-On Comfort High Hygi, M Active Micro Plus, XL Basic Shell, L Gait Trainer, Bariatric Sit-On II, S Positioning Sling, side Basic High, Poly, Kid 4-6 Hip Support Sit-On High, XS Basic Hammock, M Disposable Repo Sheet Sit-On II, M Basic Low, Net, XL Disposable High, S Twin Turner, Bariatric Active Vest, Kid 6-10 Sit-On Comfort High Hygi, XL Extension strap, 20 cm Basic Basic, Net, XS Disposable High, Kids 6-10 Basic Hammock, XL Sit-On Comfort High, XL Disposable High, XS Basic High Bariatric, 3XL Horizontal lifting support, stepped weight adjustment

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ILE	Sling, Arm, Overhead Supported	Physical Medicine	Class 1	890.3475	2023-03-15

Official Correspondent

No official correspondent registered.

US Agent Details

Mads Petersen Business: GULDMANN, INC. Email: mpe@guldmann.net Phone: (813) 2171624

Related Public Records

Same Entity

V. GULDMANN A/S

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9710050	V. GULDMANN A/S	AARHUS N Midtjylland, DK

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3020157853. Last updated year: 2026. Please use registration number 3020157853 when referencing this establishment in official correspondence.