Is this your brand? Sign in to claim ownership.
Sign in to claim this brandCristcot LLC
US
Last updated May 27, 2026
What Cristcot LLC makes
Cristcot LLC manufactures single-use rectal medication applicators designed for administering suppositories. These devices include the Sephure suppository applicator and Synalax, which are intended for straightforward, disposable application in clinical or home settings.
The company’s products are classified as Class I medical devices under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. Cristcot LLC 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 Cristcot LLC manufacture?
Cristcot LLC specializes in single-use rectal medication applicators. These devices are designed to administer suppositories in clinical or home settings. The most common category is rectal medication applicators, with examples including the Sephure suppository applicator and Synalax. These products are intended for straightforward, disposable use.
Where is Cristcot LLC based?
Cristcot LLC is based in the United States. The company’s headquarters and operations are located within the country, though specific regional offices or manufacturing sites are not detailed in the available information.
Which regulatory registries list Cristcot LLC’s devices?
Cristcot LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the United States, ensuring traceability and compliance with regulatory standards.
How are Cristcot LLC’s devices classified under FDA regulations?
Cristcot LLC’s devices fall under Class I classification according to FDA regulations. This classification applies to low-risk medical devices that pose minimal potential harm to users. The company’s rectal medication applicators, such as the Sephure suppository applicator and Synalax, meet the criteria for this category due to their straightforward design and intended single-use purpose.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- sephure.com
- —
- —
- [email protected]
- Phone
- 978-212-6380
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 080739421
Catalogue (8)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Sephure® suppository applicator | A2-10 | FDA UDI | Class I | Active |
| Sephure® suppository applicator | D0-6 | FDA UDI | Class I | Active |
| Sephure® suppository applicator | A2 | FDA UDI | Class I | Active |
| Sephure® suppository applicator | A2-30 | FDA UDI | Class I | Active |
| Sephure® suppository applicator | B3 | FDA UDI | Class I | Active |
| Sephure® suppository applicator | D0 | FDA UDI | Class I | Active |
| Synalax | Synalax | FDA UDI | Class I | Active |
| Sephure® suppository applicator | B3-10 | FDA UDI | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.