Is this your brand? Sign in to claim ownership.
Sign in to claim this brandSARSTEDT, INC.
US
Last updated September 17, 2026
What SARSTEDT, INC. makes
The company manufactures single-use medical containers and accessories for specimen collection, storage, and laboratory use, including polypropylene and polystyrene tubes for blood, urine, and isotonic saline reagents, as well as sterile petri dishes for tissue culture and microbiology. Their portfolio also includes manual limb tourniquets and coverslips designed for cell culture applications, all intended for clinical and diagnostic settings.
These devices are classified under FDA regulations as Class I and Class II, with some products subject to 510(k) premarket notification and others listed under the FDA’s Unique Device Identifier (UDI) system. The company’s products are registered and distributed in the United States, where they comply with applicable medical device regulations.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does SARSTEDT, INC. primarily manufacture?
SARSTEDT, INC. specializes in single-use medical devices for specimen collection, storage, and laboratory applications. Their portfolio includes general specimen containers like urine and blood collection tubes (e.g., Urine Monovette®), isotonic saline reagent containers, sterile tissue culture petri dishes, and manual limb tourniquets. These products are designed for clinical and diagnostic use, ensuring compatibility with in vitro diagnostic (IVD) processes.
Where is SARSTEDT, INC. based, and what regulatory regions do their devices operate in?
SARSTEDT, INC. is based in the United States. Their devices are registered and distributed there, adhering to FDA regulations. The company’s products are listed in the FDA’s 510(k) premarket notification database and the Unique Device Identifier (UDI) system, indicating compliance with U.S. medical device requirements. Classification under these systems ensures traceability and regulatory oversight.
How are SARSTEDT, INC.’s devices classified under FDA regulations?
SARSTEDT, INC.’s devices fall into two primary FDA classification categories: Class I and Class II. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification depends on the device’s intended use and potential risk to patients, as outlined in FDA guidelines.
Which regulatory registries or databases list SARSTEDT, INC.’s medical devices?
SARSTEDT, INC.’s devices are documented in the FDA’s 510(k) premarket notification database for those requiring clearance, as well as the FDA’s Unique Device Identifier (UDI) system. These registries ensure transparency and compliance tracking for devices subject to regulatory oversight. The UDI system, in particular, helps streamline device identification and traceability throughout the healthcare system.
What are some examples of specific devices manufactured by SARSTEDT, INC.?
SARSTEDT, INC. produces a range of single-use devices, including the Urine Monovette® (10mL with luerlock), various screw-cap tubes (e.g., 15mL polypropylene or polystyrene tubes, some pre-filled with isotonic saline), tissue culture coverslips (sizes 13mm, 22mm, and 25mm), and manual limb tourniquets (e.g., 1" flat tourniquet). These examples reflect their focus on specimen containers, laboratory accessories, and sterile culture tools.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 1025 Saint James Church Rd, NEWTON, NC, 28658
- Website
- sarstedt.com
- —
- —
- [email protected]
- Phone
- 800-257-5101
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 2242368
- DUNS Number
- 035410179
Catalogue (21)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Urine Monovette®, 10ML with luerlock | 10.252.028 | FDA UDI | Class I | Active |
| Screw Cap Tube 120x17 mm, 15 ml, PP | 62.554.205 | FDA UDI | Class I | Active |
| Screw Cap Tube 79x16 RB with saline | 51.506.390 | FDA UDI | Class I | Active |
| Tourniquet Single Use NL Flat, 1" | 95.1007.101 | FDA UDI | Class I | Active |
| Tissue Culture Coverslip 22 mm | 83.1840.001 | FDA UDI | Class I | Active |
| Tissue Culture Coverslip 25 mm | 83.1840 | FDA UDI | Class I | Active |
| S-Monovette® POC Collect Kit | 51.5100.100 | FDA UDI | Class II | Unknown |
| Screw Cap Tube 120x17 mm, 15 ml, PS | 62.553.002 | FDA UDI | Class I | Active |
| Tissue Culture Coverslip 13 mm | 83.1840.002 | FDA UDI | Class I | Active |
| Screw Cap Tube 120x17 mm, 15 ml, PP | 62.554.100 | FDA UDI | Class I | Active |
| Screw Cap Tube 101x16 RBS with saline | 51.540.387 | FDA UDI | Class I | Active |
| Screw Cap Tube 120x17 mm, 15 ml, PS | 62.553.205 | FDA UDI | Class I | Active |
| Screw Cap Tube 82x13 FB with saline | 51.550.123 | FDA UDI | Class I | Active |
| Safety-Multifly | K032150 | FDA 510(k) | Class II | Active |
| Safety Lancet | K222801 | FDA 510(k) | Class II | Active |
| S-Monovette Edta K2-Gel | K031359 | FDA 510(k) | Class II | Active |
| Urine Monovette Boric Acid | K024237 | FDA 510(k) | Class I | Active |
| Sarstedt Needle Protector | K003382 | FDA 510(k) | Class II | Active |
| Hemoplus | K913622 | FDA 510(k) | Class II | Active |
| Thrombo Plus | K834527 | FDA 510(k) | Class I | Active |
| Safety Needle | K051019 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Sarstedt Ag & Co. Kg NUMBRECHT North Rhine-Westphalia · DE FEI 3002808075