Medivators Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000043422 FEI 3003012447
Medivators Inc. is a medical device manufacturer based in the United States, with 5,488 devices listed and 9 FDA recalls as of 14 Nov 2026.
- Devices
- 5,488
- Registrations
- EUDAMEDFDA
- FDA recalls
- 9
Registry facts
- Registries
- FDA GUDID 2,971
- EUDAMED 89
- FDA 510(k) 1
- Device classes
- FDA Class II 1,793
- FDA Class I 1,158
- EU Class I 26
- EU Class IIa 18
- EU Class IIb 5
- Top EMDN categories
- FDA recalls
- Sites and related companies
- STERIS Ireland Ltd authorised representative
- Identifiers
- EUDAMED SRN US-MF-000043422
- FDA FEI 3003012447
- DUNS 068199363
At a glance
EU certificates
2 of 2 in force.
Market reach
- European Union
- EUDAMED actor, 2 certificates
- United States
- FDA FEI, FDA recalls
- Authorised rep.
- STERIS Ireland LtdIE
What Medivators Inc. makes
Medivators Inc. manufactures endoscopy preparation kits, reusable and single-use tubing sets for surgical irrigation and endoscopic insufflation, haemodialysis concentrates, single-use surgical instrument and endoscope cleaning utensils, endoscope channel support kits, and single-use isolation gowns. Specific products include the Endo-Carry-on Procedure Kit, Medivators Hookup, Custom Procedure Kit, and Essential Kit.
The company's devices are classified as Class I and Class II medical devices and are listed in the FDA UDI registry. Medivators Inc. is based in the United States.
Catalogue
Search and filter all 5,488 devicesShowing 1-50 of 5,488
Company details
- EUDAMED SRN
- US-MF-000043422
- FDA FEI number
- 3003012447
- DUNS number
- 068199363
- EU VAT number
- 34-1482024
- EUDAMED status
- Active
- EUDAMED registered name
- Medivators Inc.
- EUDAMED abbreviated name
- Medivators
- Registered address
- 3150, Pollok Dr, 77303, Conroe, United States
- Website
- www.steris.com
- Phone
- +1(800)444-4729
- PRRC contact
- Zeeshan Shamim
1 more person
- Daniel Davy
EUDAMED certificates
2 certificates2 valid, 0 expiredMDR 2next expiry 22 Dec 2027
BSI Group The Netherlands B.V. 2797 2 certificates
- MDR 832500 Active
Quality management system EU MDR
- Issued
- 4 Feb 2026
- Expires
- 16 Oct 2029
- Reason
- Ar srn change
- MDR 832608 Active
Quality management system EU MDR
- Issued
- 14 Jan 2026
- Expires
- 22 Dec 2027
- Reason
- Ar srn change
FDA recalls
FDA recall records list 9 recalls initiated by MEDIVATORS INC., the earliest on 2015-08-03 and the most recent on 2021-04-20. By recorded status: 9 terminated. The reasons filed fall into these groups: mechanical integrity, performance or accuracy and manufacturing or quality process. 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 0
- 2018 0
- 2019 7
- 2020 0
- 2021 1
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2021
- 20 Apr 2021 Z-1859-2021 Class II Terminated The lot may have experienced an anomaly during the manufacturing process, that could lead to an out of specification concentrate formulation.
2019
- 9 Oct 2019 Z-1772-2020 Class II Terminated Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve.
- 9 Oct 2019 Z-1773-2020 Class II Terminated Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve.
- 9 Oct 2019 Z-1774-2020 Class II Terminated Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve.
- 9 Oct 2019 Z-1775-2020 Class II Terminated Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve.
- 9 Oct 2019 Z-1776-2020 Class II Terminated Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve.
- 9 Oct 2019 Z-1777-2020 Class II Terminated Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve.
- 9 Oct 2019 Z-1778-2020 Class II Terminated Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve.
2015
- 3 Aug 2015 Z-2761-2015 Class II Terminated Hemoconcentrators may exhibit low ultrafiltration performance that is below product specification.
Frequently asked questions
How many devices does MEDIVATORS INC. have in the registry?
The registry currently lists 5488 devices for MEDIVATORS INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list MEDIVATORS INC.'s devices?
Among its 50 most recently registered devices, MEDIVATORS INC. has devices listed in EUDAMED (18 devices) and FDA GUDID (32 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do MEDIVATORS INC.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for MEDIVATORS INC.'s devices are Class I, Class IIa, Class IIb and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for MEDIVATORS INC.?
FDA recall records list 9 recalls initiated by MEDIVATORS INC., the most recent initiated on 20 Apr 2021. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What EUDAMED certificates are recorded for MEDIVATORS INC.?
EUDAMED lists 2 certificates for MEDIVATORS INC. (quality management system) under MDR. The most recent was issued on 4 Feb 2026.
What are the newest devices from MEDIVATORS INC. in the registry?
The most recently registered devices listed for MEDIVATORS INC. include Endo Carry-on Procedure Kit 4011565, Endo Carry-on Procedure Kit 4011564, Endo Carry-on Procedure Kit 4011577 and Endo Carry-on Procedure Kit 4011567.