Streck
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000013009 FEI 3017953151
Streck is a medical device manufacturer based in the United States, with 228 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II and I; EU Class B and A) and 1 FDA recall as of 13 Nov 2026.
- Devices
- 228
- Registrations
- EUDAMEDFDA
- FDA recalls
- 10 ongoing since 2021 (1 open in total)
Registry facts
- Registries
- FDA GUDID 187
- EUDAMED 42
- FDA 510(k) 38
- Device classes
- FDA Class II 154
- FDA Class I 34
- EU Class B 21
- EU Class A 15
- Top EMDN categories
- FDA recalls
- Sites and related companies
- MediMark Europe SARL. authorised representative
- Identifiers
- EUDAMED SRN US-MF-000013009
- FDA FEI 3017953151
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI, FDA recalls
- Authorised rep.
- MediMark Europe SARL.FR
What Streck makes
The company produces in vitro diagnostics (IVDs) for hematology and blood collection, including controls and calibrators for full blood count assays, reticulocyte counts, erythrocyte sedimentation rate (ESR), and glucose/hemoglobin measurements. It also manufactures evacuated blood collection tubes with sodium citrate and potassium EDTA additives, as well as viral extraction kits and cell preservation solutions for blood samples.
These devices are regulated under Class A and Class B (EU) or Class I and Class II (US) classifications, depending on the jurisdiction. They are listed in the EU’s eudamed registry, the FDA’s 510(k) clearance database, and the FDA’s Unique Device Identifier (UDI) system. The company is based in the United States.
Catalogue
Search and filter all 228 devicesShowing 1-50 of 228
Company details
- EUDAMED SRN
- US-MF-000013009
- FDA FEI number
- 3017953151
- EUDAMED status
- Active
- EUDAMED registered name
- Streck
- Registered address
- 7002, S. 109th Street, 68128, La Vista, United States
- Website
- www.streck.com
- wroyalty@streck.com
- Phone
- 1 402 537 5343
- PRRC contact
- Wendy Royalty
FDA recalls
FDA recall records list 1 recall initiated by Streck, initiated on 2017-02-23. By recorded status: 1 ongoing. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 1
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2017
- 23 Feb 2017 Z-1684-2017 Class II Open since 2017 Complaints of the 2.0ml tube stopper coming loose during phlebotomy when small diameter tube adapters were not utilized. Such adapters aid with centering small diameter tubes to properly pierce the middle of the stoppers.
Full distribution text
- 23 Feb 2017 Z-1684-2017 Class II Open since 2017 Complaints of the 2.0ml tube stopper coming loose during phlebotomy when small diameter tube adapters were not utilized. Such adapters aid with centering small diameter tubes to properly pierce the middle of the stoppers.
Frequently asked questions
How many devices does Streck have in the registry?
The registry currently lists 228 devices for Streck. Devices recorded under merged duplicate company entries are counted once.
Which registries list Streck's devices?
Among its 50 most recently registered devices, Streck has devices listed in EUDAMED (5 devices), FDA 510(k) (14 devices) and FDA GUDID (34 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Streck's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Streck's devices are Class I, Class II and IVDR Class A. Each device page shows its own class and authorisation.
Are there FDA recall records for Streck?
FDA recall records list 1 recall initiated by Streck, the most recent initiated on 23 Feb 2017. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Streck in the registry?
The most recently registered devices listed for Streck include Cell-Free DNA BCT CE, XN CHECK BF, Cell-Free DNA BCT and XN CHECK.