Is this your brand? Sign in to claim ownership.
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 6 of 26| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Microvette® 500 Z-Gel | 20.1344.899 | FDA UDI | Class I | Active |
| S-Monovette® | 04.1952.200 | FDA UDI | Class II | Active |
| Screw cap, pink | 65.716.004 | FDA UDI | Class I | Active |
| S-Monovette® | 01.1605.001 | FDA UDI | Class II | Active |
| Micro tube 1.5ml with cap | 72.687.002 | FDA UDI | Class I | Active |
| S-Monovette® | 04.1936.100 | FDA UDI | Class II | Active |
| Pipette tip 250 µl | 70.3031 | FDA UDI | Class I | Active |
| Safety-Multifly®-Needle | 85.1638.200 | FDA UDI | Class II | Active |
| Urine container 2l | 77.580 | FDA UDI | Class I | Active |
| DC900Flex ID, Quest Marlb. V | 90.2060.102 | FDA UDI | Class I | Active |
| TC Plate 12 Well, Standard, F | 83.3921.005 | FDA UDI | Class I | Active |
| Pipette tip 1250 µl XL | 70.3070.200 | FDA UDI | Class I | Active |
| Safety-Multifly®-Needle | 85.1638.935 | FDA UDI | Class II | Active |
| FB tube 2.5ml, 75x13 (round) | 60.614.027 | FDA UDI | Class I | Active |
| S-Monovette® | 04.1901.100 | FDA UDI | Class II | Active |
| S-Monovette® 1.6ml K3E | 04.1956.100 | FDA UDI | Class II | Active |
| Micro tube 1.5ml, PP | 72.687.034 | FDA UDI | Class I | Active |
| CryoPure Tube 1.8ml violet | 72.379.007 | FDA UDI | Class I | Active |
| Insert, 12 Well, PET 3µm, TL | 83.3931.300 | FDA UDI | Class I | Active |
| Tube 10ml 100x16 PP + Cap | 62.9924.289 | FDA UDI | Class I | Active |
| Tube 6.5ml, 90x13mm, PP | 62.503.210 | FDA UDI | Class I | Active |
| BloodGas Monovette®2ml | 05.1147.120 | FDA UDI | Class II | Active |
| S-Monovette® | 01.1605.100 | FDA UDI | Class II | Active |
| Micro tube 1.5ml, PP | 72.692.005 | FDA UDI | Class I | Active |
| Bl 1200 | 90.2064.119 | FDA UDI | Class I | Active |
| Screw cap, neutral | 65.163 | FDA UDI | Class I | Active |
| Multiply®-Pro cup 0.5ml, PP | 72.735.992 | FDA UDI | Class I | Active |
| Transfer pipette 1ml | 86.1180 | FDA UDI | Class I | Active |
| Pipette tip | 70.3070 | FDA UDI | Class I | Active |
| Filter tip 100 µl | 70.3030.375 | FDA UDI | Class I | Active |
| Pipette tip 20 µl | 70.3020.110 | FDA UDI | Class I | Active |
| Multiply®-Pro mix. colour | 72.737.992 | FDA UDI | Class I | Active |
| Microvette® 200 K2E | 20.1286.100 | FDA UDI | Class I | Active |
| Microvette® 500 Z | 20.1343.100 | FDA UDI | Class I | Active |
| S-Monovette® | 04.1929.100 | FDA UDI | Class II | Active |
| Sc Mtube, 2ml, Gwb, Blu Cap, St | 72.694.321 | FDA UDI | Class I | Active |
| Screw cap, violet | 65.716.008 | FDA UDI | Class I | Active |
| Micro tube 0.5ml, PP | 72.730.028 | FDA UDI | Class I | Active |
| Pipette tip 1000 µl | 70.3050.100 | FDA UDI | Class I | Active |
| Micro tube 1.5ml, PP | 72.607.034 | FDA UDI | Class I | Active |
| Micro tube 2ml, PP | 72.685.701 | FDA UDI | Class I | Active |
| Recapper RC1200 Hitachi, 115V | 90.197.001 | FDA UDI | Class I | Active |
| 2.0ml SC Micro Tube DNA LB | 72.694.700 | FDA UDI | Class I | Active |
| SafeSeal tube 2ml, yellow | 72.695.004 | FDA UDI | Class I | Active |
| De-/Recapper 900 Flex ID, 115V | 90.2060.089 | FDA UDI | Class I | Active |
| Tube 5ml, 57x15.3mm, PP | 60.558.001 | FDA UDI | Class I | Active |
| SafeSeal tube 0.5ml, green | 72.704.005 | FDA UDI | Class I | Active |
| Micro tube 1.5ml with cap | 72.687.027 | FDA UDI | Class I | Active |
| Pipette tip 1000 µl | 70.3050.110 | FDA UDI | Class I | Active |
| S-Monovette® | 06.1666.120 | FDA UDI | 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.