FDA Registration
Active
🇺🇦 Ukraine
Active Trainer, XXL
Reg #: 3020157853
·
FEI: 3020157853
·
Expires 2025
Products
1
Proprietary Names
240
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- GULDMANN-UKRAINE LTD
- Registration Number
- 3020157853
- FEI Number
- 3020157853
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Shevchenko Str. 73, Kulykiv L'Viv Region
- City
- Lviv L'vivs'ka Oblast'
- Country
- UA
Owner / Operator
- Firm Name
- V. GULDMANN A/S
- Operator Number
- 9027662
- Address
- GRAHAM BELLS VEJ 23 A, --
- City
- AARHUS N
- State
- DK-NOTA
- Postal Code
- DK-8200
- Country
- DK
US Agent
- Business Name
- GULDMANN, INC.
- Contact Name
- Mads Petersen
- Address
- 14401 McCormick Drive, Suite A
- City
- Tampa
- State
- FL
- ZIP
- 33626
- Country
- US
- [email protected]
- Phone
- 813 2171624
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sling, Arm, Overhead Supported | ILE | Class 1 | Physical Medicine | No | 2023-03-15 |
Proprietary Names
Active Trainer, XXL
Disposable High, Bariatric, XL/XXL
Basic Comfort High, Poly, L
Basic Low, Net, M
Active Trainer, XL
Basic Low, Net, L
Basic High Bariatric, 4XL
Active Trainer, Kid 6-10
Sit-On Comfort High Hygi, XS
Disposable High, Bariatric, XXL/XXXL
Sit-On Comfort, Kid 6-10
Active Micro Plus, L
Gait Trainer, XL
Sit-On High, L
Sit-On High II, XL
Twin Turner, Large
Basic Comfort High, Net, XL
Active Micro Plus, M
Basic Comfort High, Poly, M
Disposable High, Bariatric, L/XL
Disposable Horizontal, Standard
Basic Low, Poly, XXL
Dispo. Gait Trainer, M
Dispo. Micro Plus XS, Box of 5 slings
Sit-On High, M
Basic Hammock, XS
Horizontal Sling, Standard
Sit-On II, L
Sit-On Comfort High, S
Sit-On Comfort, XL
Sit-On, XS
Sit-On High, S
Disposable Comfort High, XL
Basic Basic, Poly, S
Dispo. Gait Trainer, L
Sit-On High II, L
Sit-On High II, XXXL
Basic Basic, Net, L
Extension strap, 20 cm
Disposable Twin Turner II, Regular
Disposable High, Kids 6-10
Basic Basic, Net, S
Disposable High II, Kids 6-10
Disposable High, XS
Positioning Sling, side
Basic Basic, Poly, Kid 10-14
Sit-On, Kid 4-6
Active Micro, Poly, XXL
Repositioning Sling, Bariatric Box 5
Sit-On High, XS
Sit-On Comfort High, XS
Sit-On Comfort High, Kid 6-10
Sit-On II, XL
Active Micro Plus, XXL
Dispo. Gait Trainer, XXL
Basic High, Net, XXL
Lifting hanger SMALL
Horizontal lifter, Foldable, 1 strap version
Disposable Comfort High, M
Basic Basic, Poly, XXL
Standing Sling, S/M
Basic Basic, Net, Kid 10-14
Basic Comfort High, Poly, XL
Gait Trainer, M
Sit-On Comfort, Kid 4-6
Basic High, Net, Kid 10-14
Custom Amputee, L
Sit-On Comfort High, XXXL
Basic High Net, Kid 4-6
Standing Shell Vest, XS
Basic Comfort High, Net, S
Active Micro Plus, Kid 10-14
Active Trainer, M
Sit-On High II, M
Disposable High II, XL
Basic Low, Poly, XL
Basic Low, Net, XL
Basic Comfort High, Poly, S
Twin Turner, Bariatric
Custom Amputee, M
Basic Comfort High, Net, XS
Repositioning Sling, Spacer
Disposable Comfort High, L
Basic High, Poly, XXL
Disposable High II, XS
Basic Low, Poly, XS
Basic High, Net, XL
Standing Shell Vest, Kid 6-10
Disposable High II, M
Custom Amputee, XL
Sit-On High II, Kid 6-10
Sit-On Comfort, S
Basic Basic, Poly, Kid 6-10
Basic Basic, Net, XXL
Dispo. Gait Trainer, S
Active Vest, Kid 10-16
Multi Support Sling
Active Micro, Poly, M
Gait Trainer, L
Basic Low, Poly, M
Sit-On, M
Standing Shell Vest, Kid 10-16
Basic High, Net, M
Disposable High II, S
Sit-On High, Kid 6-10
Basic High, Net, S
Basic Basic, Poly, XXXL
Repositioning Sling, TENCEL Box 10
Basic Basic, Poly, M
Disposable Leg Sling II
Basic Low, Net, XS
Standing Sling, XL
Twin Turner, Regular
Basic Shell, XS
Sit-On, Kid 6-10
Extension strap, 30 cm
Dispo. Micro Plus XL, Box of 5 slings
Basic High, Net, Kid 6-10
Basic Basic, Poly, XS
Dispo. Micro Plus L, Box of 5 slings
Basic Comfort High, Poly, XS
Basic Shell, XL
Sit-On II, XS
Active Micro Plus, Kid 6-10
Custom Amputee, S
Sit-On Comfort High Hygi, L
Basic Basic, Poly, XL
Active Micro Plus, XL
Dispo. Micro Plus XXL, Box of 5 slings
Disposable Comfort High, XS
Sit-On, XL
Sit-On II, M
Basic High Bariatric, 5XL
Disposable High, S
Disposable Comfort High, S
Custom Amputee, XS
Active Vest, Kid 6-10
Sit-On Comfort High Hygi, XL
Basic Basic, Net, M
Modified Sling, Net
Basic High, Poly, S
Basic Basic, Poly, Kid 4-6
Basic Low, Net, S
Sit-On Comfort, M
Cross hanger - 400kg
Lifting hanger MEDIUM
Horizontal lifter, Foldable, 2 strap version
Active Trainer, S
Active Micro Plus, S
Disposable High II, L
Repositioning Sling, Spacer, 6 loops
Sit-On Comfort High Hygi, S
Basic High, Poly, L
Sit-On, S
Sit-On II, Kid 4-6
Basic Basic, Net, XS
Disposable High, XL
Basic Hammock, XL
Sit-On Comfort High, XL
Basic High Bariatric, 3XL
Basic Low, Net, XXL
Dispo. Micro Plus M, Box of 5 slings
Sit-On High, XL
Active Micro, Poly, S
Basic Shell, M
Basic Basic, Net, XL
Active Micro Plus, XS
Sit-On Comfort High, XXL
Disposable Repo Sheet
Lifting hanger X-SMALL
Sit-On High II, S
Sit-On High II, Kid 4-6
Active Trainer, Kid 10-14
Dispo. Micro Plus S, Box of 5 slings
Basic Comfort High, Net, L
Basic Basic, Poly, L
OR Sling, Poly, M
Horizontal lifting support, stepless weight adjustment
Sit-On Comfort High Hygi, M
Basic Shell, L
Gait Trainer, Bariatric
Sit-On II, S
Basic High, Net, L
Basic High, Poly, Kid 10-14
Basic High, Poly, M
Sit-On Comfort High, Kid 4-6
Sit-On, L
Active Micro, Poly, L
Gait Trainer, S
Basic Comfort High, Net, XXL
OR Sling, Poly, L
Basic Shell, S
Sit-On Comfort High, M
Repositioning Sling, Grey net Box 10
Basic Low, Poly, L
Disposable High II, XXL
Sit-On Comfort High, L
Sit-On Comfort, L
Dispo. Gait Trainer, XL
Basic High, Poly, Kid 6-10
Sit-On II, Kid 6-10
Repositioning Sling, Poly
Basic Low, Poly, S
Disposable Multi Support Sling
Basic High, Poly, XS
Pannus Support
Modified Sling, Poly
Turner
Active Trainer, L
Disposable Comfort High, XXL
Basic High, Poly, Kid 4-6
Basic Hammock, S
Hip Support
Standing Sling, XXL
Active Vest, Kid 4-6
Basic Hammock, M
Sit-On Comfort, XS
Disposable Repo w. Smart Loops
Basic High, Net, XS
Standing Sling, L
Repositioning Sling Box 10
Disposable Twin Turner II, Large
Disposable High, L
H-hanger
Horizontal lifting support, stepped weight adjustment
Connecting bar + cross hanger 500kg
Basic Basic, Net, Kid 4-6
Basic Basic, Net, Kid 6-10
Gait Trainer, XXL
Active Trainer, XS
Leg Sling Box of 10 pcs
Basic Comfort High, Net, M
Repositioning Sling, Short, Box 10
Active Micro Plus, Kids 4-6
Disposable High, XXL
Basic High, Poly, XL
Basic Hammock, L
Sit-On High II, XS
Disposable High, M
Cross hanger - 500kg
Establishment Types
Manufacture Medical Device