FDA Registration
Active
🇩🇪 Germany
Baxter Medical Systems GmbH + Co. KG
Reg #: 3007143268
·
FEI: 3007143268
·
Expires 2026
Products
12
Proprietary Names
11
Establishment Types
5
Classifications
12
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Registration Details
- Registration Name
- Baxter Medical Systems GmbH + Co. KG
- Registration Number
- 3007143268
- FEI Number
- 3007143268
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Carl-Zeiss-Str. 7-9
- City
- SAALFELD Thuringia
- Country
- DE
Owner / Operator
- Firm Name
- BAXTER HEALTHCARE CORPORATION
- Operator Number
- 1417572
- Address
- One Baxter Parkway
- City
- Deerfield
- State
- IL
- Postal Code
- 60015
- Country
- US
- Correspondent
- Maha Nolasco
US Agent
- Business Name
- BAXTER HEALTHCARE CORPORATION
- Contact Name
- Maha Nolasco
- Address
- 25212 W. IL Route 120, RLT-04
- City
- Round Lake
- State
- IL
- ZIP
- 60073
- Country
- US
- [email protected]
- Phone
- 224 2706181
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Camera, Surgical And Accessories | KQM | Class 1 | General, Plastic Surgery | No | 2022-01-10 |
| Light, Surgical, Floor Standing | FSS | Class 2 | General, Plastic Surgery | No | 2022-01-10 |
| Cart, Emergency, Cardiopulmonary (Excluding Equipment) | BZN | Class 1 | Anesthesiology | No | 2024-02-29 |
| Table, Operating-Room, Electrical | GDC | Class 1 | General, Plastic Surgery | No | 2022-01-10 |
| Holder, Head, Radiographic | IWY | Class 1 | Radiology | No | 2022-01-10 |
| Lamp, Surgical | FTD | Class 2 | General, Plastic Surgery | No | 2022-01-10 |
| Light, Surgical, Instrument | FSQ | Class 2 | General, Plastic Surgery | No | 2022-01-10 |
| Table, Radiologic | KXJ | Class 2 | Radiology | No | 2022-01-10 |
| Light, Surgical, Ceiling Mounted | FSY | Class 2 | General, Plastic Surgery | No | 2022-01-10 |
| Table, Surgical With Orthopedic Accessories, Ac-Powered | JEA | Class 1 | General, Plastic Surgery | No | 2022-01-10 |
| Device, Medical Examination, Ac Powered | KZF | Class 1 | General Hospital | No | 2022-01-10 |
| Lamp, Operating-Room | FQP | Class 2 | General, Plastic Surgery | No | 2022-01-10 |
Proprietary Names
OR Camera (TruVidia HD, 4K Camera, 4K Refreshing Unit) and accessories [Baxter]
Surgical Light (TruLight 5000/3000) and accessories [Baxter]
Trolley and Accessories by iTD GmbH, compact cart by iTD GmbH
Advance Table [Allen]
PST and accessories [Baxter]
TruSystem and accessories [Baxter]
Head Positioning Accessories [Baxter]
Surgical Light System (TruLight 3000, TruLight 5000) and accessories [Baxter]
TruLight 1000 Examination Light and accessories [Baxter]
Green Series Exam Lights (Light IV, 300, 600, 900) and Accessories [a Welch Allyn, Inc. Tijuana Product]
Surgical Light (TruLight 5000/3000, Helux Pro) and accessories [Baxter]
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198
Export Device to the United States But Perform No Other Operation on Device
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility