FDA Registration
Active
🇩🇪 Germany
HENRY SCHEIN SERVICES GMBH
Reg #: 3009142030
·
FEI: 3009142030
·
Expires 2026
Products
7
Proprietary Names
6
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- HENRY SCHEIN SERVICES GMBH
- Registration Number
- 3009142030
- FEI Number
- 3009142030
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Am Heisterbusch 9
- City
- Gallin Mecklenburg-Western Pomerania
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K191865
Owner / Operator
- Firm Name
- HENRY SCHEIN, INC.
- Operator Number
- 2411236
- Address
- 135 DURYEA RD., --
- City
- Melville
- State
- NY
- Postal Code
- 11747
- Country
- US
- Correspondent
- Tracey Alexander
US Agent
- Business Name
- Henry Schein, Inc.
- Contact Name
- Tracey Alexander
- Address
- 135 Duryea Road, E-355
- City
- Melville
- State
- NY
- ZIP
- 11747
- Country
- US
- [email protected]
- Phone
- 631 4543003
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mirror, Mouth | EAX | Class 1 | Dental | No | 2025-07-16 |
| Activator, Ultraviolet, For Polymerization | EBZ | Class 2 | Dental | No | 2025-02-27 |
| Caries Detector, Laser Light, Transmission | NTK | Class 2 | Dental | No | 2025-02-27 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2025-02-27 |
| Absorber, Saliva, Paper | KHR | Class 1 | Dental | No | 2025-07-16 |
| Articulators | EJP | Class 1 | Dental | No | 2025-07-16 |
| Scissors, Orthopedic, Surgical | HRR | Class 1 | Orthopedic | No | 1992-07-28 |
Proprietary Names
Mirror Disposable Dental
Smartlite Pro Sleeves Refill
Fingertip Pulse Oximeter
Contour Neck Bibs
Disposable Articulator Slotted
SCISSORS, ORTHOPEDIC, SURGICAL
Establishment Types
Export Device to the United States But Perform No Other Operation on Device