Sheathing Technologies, Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000044559 FEI 1000135740
Sheathing Technologies, Inc. is a medical device manufacturer based in the United States, with 631 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II; EU Class IIa and I) and 1 FDA recall as of 13 Nov 2026.
- Devices
- 631
- Registrations
- EUDAMEDFDA
- FDA recalls
- 11 ongoing
Registry facts
- Registries
- FDA GUDID 461
- EUDAMED 375
- FDA 510(k) 7
- Device classes
- FDA Class II 441
- EU Class IIa 119
- EU Class I 70
- Top EMDN categories
- FDA recalls
- Sites and related companies
- MDSS GmbH authorised representative
- Identifiers
- EUDAMED SRN US-MF-000044559
- FDA FEI 1000135740
- DUNS 806806220
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA FEI, FDA recalls
- Authorised rep.
- MDSS GmbHDE
Catalogue
Search and filter all 631 devicesShowing 1-50 of 631
Company details
- EUDAMED SRN
- US-MF-000044559
- FDA FEI number
- 1000135740
- DUNS number
- 806806220
- EUDAMED status
- Active
- EUDAMED registered name
- Sheathing Technologies, Inc.
- EUDAMED abbreviated name
- STI
- Registered address
- 675, Jarvis Drive, 95037, Morgan Hill, United States
- Website
- www.sheathes.com
- Phone
- 4087822720
- PRRC contact
- Gretchen Olson
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 4 Aug 2031
BSI Group The Netherlands B.V. 2797 1 certificate
- MDR 815976 Active
Quality management system EU MDR
- Issued
- 5 Aug 2026
- Expires
- 4 Aug 2031
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 1
- 2026 0
2025
- 17 Nov 2025 Z-1006-2026 Class II Ongoing Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk.
From the company website
Sheathing Technologies, Inc. is headquartered in Morgan Hill, California. We offer the most extensive selection of medical probe cover sizes and shapes available.
Frequently asked questions
How many devices does Sheathing Technologies, Inc. have in the registry?
The registry currently lists 631 devices for Sheathing Technologies, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sheathing Technologies, Inc.'s devices?
Among its 50 most recently registered devices, Sheathing Technologies, Inc. has devices listed in EUDAMED (50 devices).
What risk classes do Sheathing Technologies, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Sheathing Technologies, Inc.'s devices are Class I and Class IIa. Each device page shows its own class and authorisation.
Are there FDA recall records for Sheathing Technologies, Inc.?
FDA recall records list 1 recall initiated by Sheathing Technologies, Inc., the most recent initiated on 17 Nov 2025. 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 EUDAMED certificates are recorded for Sheathing Technologies, Inc.?
EUDAMED lists 1 certificate for Sheathing Technologies, Inc. (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 5 Aug 2026.
What are the newest devices from Sheathing Technologies, Inc. in the registry?
The most recently registered devices listed for Sheathing Technologies, Inc. include Ultrashcallsondenabdeckung, Sterile, Specialty Ultrasound Probe Cover with 20ml Sterile Gel & 2 Elastics, Rolled, Sterile, Extended Field Ultrasound Probe & Cord Cover with 20ml Sterile Gel & 2 Elastics, Folded and Sterile, Extended Field Ultrasound Probe & Cord Cover with 20ml Sterile Gel & 2 Elastics, Rolled.