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Sign in to claim this brandSarstedt Aktiengesellschaft & Co.KG
US
Last updated May 24, 2026
What Sarstedt Aktiengesellschaft & Co.KG makes
Sarstedt manufactures single-use in vitro diagnostic (IVD) containers and accessories for laboratory and clinical use, including blood collection tubes with anticoagulants, urine specimen containers, pipette tips, test tube caps, and tissue culture petri dishes. Their portfolio also includes robotic transfer systems for laboratory slides and microscope slides, as well as cryogenic storage tubes for biological samples. Additional products include general specimen containers and screw caps for various tube types.
The company’s devices are regulated under FDA’s UDI (Unique Device Identification) system and fall into Class I and Class II risk categories, depending on their intended use. These products are listed in the FDA’s UDI database, ensuring traceability and compliance with U.S. medical device regulations. The manufacturer operates from the United States.
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 manufacture?
Sarstedt produces a range of single-use in vitro diagnostic (IVD) devices primarily focused on laboratory and clinical applications. These include blood collection tubes with anticoagulants, urine specimen containers, pipette tips, test tube caps, tissue culture petri dishes, and robotic transfer systems for microscope slides. Their portfolio also covers general specimen containers and cryogenic storage tubes for biological samples, ensuring compatibility with various diagnostic workflows.
Where is Sarstedt based, and how does this affect its regulatory compliance?
Sarstedt operates from the United States, which means its devices are subject to U.S. medical device regulations, including the FDA’s Unique Device Identification (UDI) system. The company’s products are listed in the FDA’s UDI database, helping ensure traceability and compliance with U.S. requirements for medical devices. This registration supports transparency and regulatory tracking for healthcare providers and authorities.
Which regulatory registries list Sarstedt’s devices, and why is this important?
Sarstedt’s devices are listed in the FDA’s UDI database, which is a central registry for tracking medical devices in the U.S. This listing is important because it provides a standardized way to identify and trace devices throughout their lifecycle, ensuring proper monitoring, recall management, and compliance with FDA regulations. It also helps healthcare providers verify device details, such as manufacturer information and intended use.
How are Sarstedt’s devices classified under U.S. regulations, and what does this mean?
Sarstedt’s devices are classified as either Class I or Class II under FDA regulations, depending on their intended use and risk level. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher risk and require special controls to ensure safety and effectiveness. This classification helps determine the regulatory pathway and oversight required for each product, ensuring appropriate scrutiny based on potential patient impact.
What kinds of in vitro diagnostic (IVD) accessories does Sarstedt specialize in, and how do they support laboratory workflows?
Sarstedt specializes in single-use IVD accessories like pipette tips, robotic transfer systems for microscope slides, and various caps for test tubes and reservoirs. These products are designed to enhance precision, reduce contamination risks, and streamline laboratory processes. For example, their pipette tips ensure accurate liquid handling, while robotic transfer systems improve efficiency in slide processing, making them essential for modern diagnostic and research workflows.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- sarstedt.com
- —
- —
- [email protected]
- Phone
- +1(800)257-5101
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 388000270
Catalogue (1265)
Page 2 of 26| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| SafeSeal tube 2ml, violet | 72.695.007 | FDA UDI | Class I | Active |
| S-Monovette® | 02.1726.001 | FDA UDI | Class II | Active |
| Pipette tip | 70.3070.275 | FDA UDI | Class I | Active |
| Sample cup for Cobas Bio | 73.910.004 | FDA UDI | Class I | Active |
| Microvette® 200 FH | 20.1289.100 | FDA UDI | Class I | Unknown |
| Tube 5ml, 75x12mm, PS | 55.476.061 | FDA UDI | Class I | Active |
| Transport swab 101x16.5mm | 80.625 | FDA UDI | Class I | Active |
| Micro tube 1.5ml, PP | 72.607.772 | FDA UDI | Class I | Active |
| Micro tube 0.5ml, PP | 72.785.005 | FDA UDI | Class I | Active |
| Micro tube 2ml, PP | 72.609.041 | FDA UDI | Class I | Active |
| Tube 30ml, 107x25mm, PP | 62.543.030 | FDA UDI | Class I | Active |
| micro tube 0, 5ml | 72.730.070 | FDA UDI | Class I | Active |
| Micro tube 1.3ml LH | 41.1503.105 | FDA UDI | Class I | Active |
| Archiving Cap | 65.647.300 | FDA UDI | Class I | Active |
| Multivette® 600 K3E | 15.1671.100 | FDA UDI | Class I | Unknown |
| TC Plate 24 Well, Standard, F | 83.3922 | FDA UDI | Class I | Active |
| Container 70ml 55x44 PP+Cap | 75.9922.721 | FDA UDI | Class I | Active |
| Micro tube 2ml, PP | 72.609.056 | FDA UDI | Class I | Active |
| Minivette® POCT 50µl LH | 17.2112.050 | FDA UDI | Class I | Active |
| Round cuvette, PP | 68.752 | FDA UDI | Class I | Active |
| Urine Monovette® 10ml | 10.252.020 | FDA UDI | Class I | Active |
| SafeSeal tube 0.5ml, yellow | 72.704.004 | FDA UDI | Class I | Active |
| Micro tube 1.3ml K3E | 41.1504.105 | FDA UDI | Class I | Active |
| Insert, 12 Well, PET 0.4µm, TP | 83.3931.041 | FDA UDI | Class I | Active |
| Micro tube 2ml with cap | 72.694 | FDA UDI | Class I | Active |
| Micro tube 2ml, PP | 72.694.107 | FDA UDI | Class I | Active |
| TC Plate 96 Well, Suspension, C | 83.3926.500 | FDA UDI | Class I | Active |
| Tube 10 ml 92 x 15 ml | 62.610.202 | FDA UDI | Class I | Active |
| 0.5ml SC Micro Tube PCR-PT | 72.785.405 | FDA UDI | Class I | Active |
| Safety-Multifly®-Needle | 85.1642.235 | FDA UDI | Class II | Active |
| Tube 15ml, 120x17mm, PS | 62.553.020 | FDA UDI | Class I | Active |
| Screw cap, neutral | 65.716.725 | FDA UDI | Class I | Active |
| SafeSeal tube 0.5ml, blue | 72.704.006 | FDA UDI | Class I | Active |
| Multifly®-Needle | 85.1640.035 | FDA UDI | Class II | Active |
| Faeces tube 76x20mm | 80.734.301 | FDA UDI | Class I | Active |
| Tube 3.5ml, 92x13 (flat), PP | 60.613.010 | FDA UDI | Class I | Active |
| Micro tube 1.3ml LH | 41.1393.106 | FDA UDI | Class I | Active |
| Micro tube 0.5ml, PP | 72.785 | FDA UDI | Class I | Active |
| Sample cup 2ml for Hitachi | 73.666 | FDA UDI | Class I | Active |
| Biosphere® Screw Cap, black | 65.716.227 | FDA UDI | Class I | Active |
| Micro tube 2.0ml, blue | 72.691.006 | FDA UDI | Class I | Active |
| Safety-Needle | 85.1441.200 | FDA UDI | Class II | Active |
| Micro tube 1.5ml, PP | 72.703.036 | FDA UDI | Class I | Active |
| Blood Culture Adapter LongNeck | 14.1207 | FDA UDI | Class II | Active |
| SafeSeal tube 2ml, brown | 72.695.001 | FDA UDI | Class I | Active |
| Cap for 125ml cup | 76.1477.100 | FDA UDI | Class I | Active |
| Urine Monovette® 10ml bor.acid | 10.253 | FDA UDI | Class I | Active |
| Sample cup 1.5ml, PS | 73.641.106 | FDA UDI | Class I | Active |
| Microvette® 200 LH | 20.1292.100 | FDA UDI | Class I | Active |
| Multi-Adapter | 14.1205.050 | FDA UDI | Class II | Active |
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