SARSTEDT, INC.
US Last updated 23 Oct 2026
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- Devices
- 20
- Registries
- GUDIDFDA 510(k)FDA
- FDA recalls
- 1
Catalogue
Urine Monovette®, 10ML with luerlock 10.252.028 Ref 10.252.028
Screw Cap Tube 120x17 mm, 15 ml, PP 62.554.205 Ref 62.554.205
Screw Cap Tube 79x16 RB with saline 51.506.390 Ref 51.506.390
Tourniquet Single Use NL Flat, 1" 95.1007.101 Ref 95.1007.101
Tissue Culture Coverslip 22 mm 83.1840.001 Ref 83.1840.001
Tissue Culture Coverslip 25 mm 83.1840 Ref 83.1840
S-Monovette® POC Collect Kit 51.5100.100 Ref 51.5100.100
Screw Cap Tube 120x17 mm, 15 ml, PS 62.553.002 Ref 62.553.002
Tissue Culture Coverslip 13 mm 83.1840.002 Ref 83.1840.002
Screw Cap Tube 120x17 mm, 15 ml, PP 62.554.100 Ref 62.554.100
Screw Cap Tube 101x16 RBS with saline 51.540.387 Ref 51.540.387
Screw Cap Tube 120x17 mm, 15 ml, PS 62.553.205 Ref 62.553.205
Screw Cap Tube 82x13 FB with saline 51.550.123 Ref 51.550.123
Safety-Multifly Ref K032150
Safety Lancet Ref K222801
S-Monovette Edta K2-Gel Ref K031359
Urine Monovette Boric Acid Ref K024237
Sarstedt Needle Protector Ref K003382
Hemoplus Ref K913622
Safety Needle Ref K051019
FDA recalls
2008
- 27 Aug 2008 Z-0114-2009 Unclassified (pre-2012) Terminated The product from this lot may not retract the lancet into the safe position inside the lancet body after the trigger is actuated.
FDA establishments
- Sarstedt AG & Co. KG NUMBRECHT North Rhine-Westphalia · DE FEI 3002808075
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.
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.
Information
- Country
- US
- Address
- 1025 Saint James Church Rd, NEWTON, NC, 28658
- Website
- sarstedt.com
- [email protected]
- Phone
- 800-257-5101
- FDA FEI number
- 2242368
- DUNS number
- 035410179