FDA Registration
Active
🇩🇪 Germany
ONDAL MEDICAL SYSTEMS GMBH
Reg #: 3012272052
·
FEI: 3012272052
·
Expires 2026
Products
4
Proprietary Names
22
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- ONDAL MEDICAL SYSTEMS GMBH
- Registration Number
- 3012272052
- FEI Number
- 3012272052
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Wellastr. 6
- City
- Huenfeld Hesse
- Country
- DE
Owner / Operator
- Firm Name
- Ondal Medical Systems GmbH
- Operator Number
- 10052435
- Address
- Wellastr. 6
- City
- Huenfeld
- State
- Hesse
- Postal Code
- 36088
- Country
- DE
- Correspondent
- Klaus Steger
US Agent
- Business Name
- Ondal Medical Systems of America
- Contact Name
- Christopher Walters
- Address
- 540 Eastpark Court, Suite A
- City
- Sandston
- State
- VA
- ZIP
- 23150
- Country
- US
- [email protected]
- Phone
- 804 5321444
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stand, Infusion | FOX | Class 1 | General Hospital | No | 2016-07-28 |
| System, Digital Image Communications, Radiological | LMD | Class 1 | Radiology | No | 2024-10-25 |
| Light, Surgical, Ceiling Mounted | FSY | Class 2 | General, Plastic Surgery | No | 2025-01-17 |
| Table, Operating-Room, Ac-Powered | FQO | Class 1 | General, Plastic Surgery | No | 2016-07-28 |
Proprietary Names
INFUSION CROSS STRAIGHT
INFUSION RACK
INFUSION CROSS BEND
NuCart
VALiA Light Pro (Third Party Light)
Med. Supply Unit: Service Head M6(-200; -400; -600; -800; -1000; -Lifter; -Lifter-S); MediSpace; SpacePoint;
X-Ray Shield & Monitor Carrier System: VALiA XRAY
MRI Monitor Carrier: Vista,(VALiA+, 1-fold; MRI; VALiA+, 2-fold, MRI)
Heavy Duty Arms: VALiA X,(EA1; EA2; Boom; EA1/MD; MD60; MD90; MD110; CT110-S; CT110; DT; V; DT; H)
Heavy Duty Pendant: MediHoist,(Friction; Power Rail)
Monitor Carrier System: VALiA Display;
Suspension System Arms: VALiA,(S; S1; S1+; S2; S2+; S3; C1; C2; C1S1; C1S1+; C1S2; C2S1; C2S1+; C2S2; S/C; Triple Plate)
MRI Suspension System: VALiA,(C1, MRI; C2, MRI; C, EA2, MRI; S/C,CT110,MRI)
Monitor Carrier: CEMOR,( 1; 2; 3; 4; 6; 8; LS; C4; C6; C8; C LS; X 2; X LS) VarioView, (1-fold; 2-fold; 26; 32)
Mon. Carrier Accessories: Vista,(handle,steel; handle adapter; handle steriliz.; handle dispos.; VESA 200 adapter; Box)
Heavy Duty Arms: MediBoom,(Single; Dual; Friction; Air; AirPlus; Inverted; XL; XXL); MediLift (150; 210; 250; 180; XL)
MRI Spring Arms: VALiA,(MD23+; MRI; MD26+; MRI)
Monitor Carrier: Vista,(VALiA; VALiA+; OSP)
Med. Supply Unit: Ceiling Unit M20 (w/MediBoom-H; w/MediLift-H; w/VALiA X-H; w/MediBoom-V; w/MediLift-V; w/VALiA X-V)
Suspension Spring Arms: VALiA,(L; MD; XRS; LCH)
Suspension System Arms: ACROBAT 3000; ONDASPACE; SPACEPORT; Central Axis; Hybrid Central Axis;
Suspension System Arms: ACROBAT 2000; ACROBAT SWING; ACROBAT 77;
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility