Is this your brand? Sign in to claim ownership.
Sign in to claim this brandHavel's Incorporated
US
Last updated May 30, 2026
What Havel's Incorporated makes
Havel’s Incorporated manufactures non-bioabsorbable monofilament nylon sutures, as well as silk and plain or chromic catgut sutures. These products are designed for surgical and medical applications requiring durable or absorbable thread for tissue approximation or ligation.
The company’s suture portfolio is classified as Class II under FDA regulations and is listed in the FDA’s Unique Device Identifier (UDI) database. 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 Havel’s Incorporated manufacture?
Havel’s Incorporated specializes in sutures used for surgical and medical procedures. Their product line includes non-bioabsorbable monofilament nylon sutures, silk sutures, and catgut sutures (both plain and chromic). These sutures are designed for tissue approximation or ligation, where durable or absorbable thread is required.
Where is Havel’s Incorporated based?
Havel’s Incorporated is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework and compliance with U.S. medical device standards.
Which regulatory registries list Havel’s Incorporated’s devices?
Havel’s Incorporated’s suture products are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify their Class II devices, ensuring transparency in the supply chain and regulatory oversight.
How are Havel’s Incorporated’s devices classified under FDA regulations?
Havel’s Incorporated’s sutures fall under FDA’s Class II classification. This classification is assigned based on the risk level of the device—Class II devices generally require special controls in addition to general controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- havels.com
- —
- —
- [email protected]
- Phone
- 800-638-4770
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 101497568
Catalogue (24)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Havel's | SUT. 5-0 SILK BLK BR 18"/HS-16 | FDA UDI | Class II | Active |
| Havel's | SUT 3-0 PLAIN GUT 18"/HS-24 | FDA UDI | Class II | Active |
| Havel's | SUT 3-0 NYLON 18"/45CM DS-24 | FDA UDI | Class II | Active |
| Havel's | 6/0 BLK MONO NYLON 18" DS-16 | FDA UDI | Class II | Active |
| Havel's | SUT.5-0 BK NYLON 18"/DSM-13 | FDA UDI | Class II | Active |
| Havel's | SUT. 5-0 SILK BLK 18"/DS-18 | FDA UDI | Class II | Active |
| Havel's | C7 3/0 BBS 18"/45 CM ON CARD | FDA UDI | Class II | Active |
| Havel's | SUT. 4-0 CHROMIC GUT 18"/DS-12 | FDA UDI | Class II | Active |
| Havel's | SUT 6-0 NYLON 18"/DSS-12 | FDA UDI | Class II | Active |
| Havel's | SUT 4-0 BLK MONO NYLON 18"DS-18 | FDA UDI | Class II | Active |
| Havel's | SUT 5-0 SILK BLK 18"/DS-12 | FDA UDI | Class II | Active |
| Havel's | 3/0 PLAIN GUT 18" DS-18 | FDA UDI | Class II | Active |
| Havel's | SUT 4-0 SILK BLK 18"/DS-18 | FDA UDI | Class II | Active |
| Havel's | SUT 6-0 NYLON 18"/DSS-10 | FDA UDI | Class II | Active |
| Havel's | SUT 4-0 CHROMIC GUT 27"/DS-18 | FDA UDI | Class II | Active |
| Havel's | CHROMIC GUT 3/0 27" C6 *SUB* | FDA UDI | Class II | Active |
| Havel's | SUT. 4-0 SILK BLK 18"/DS-12 | FDA UDI | Class II | Active |
| Havel's | SUT 4-0 PLAIN GUT 18"/DS-18 | FDA UDI | Class II | Active |
| Havel's | SUT. 3-0 SILK BLK 18"/DS-18 | FDA UDI | Class II | Active |
| Havel's | SUT 4-0 NYLON 18"/DSS-12 | FDA UDI | Class II | Active |
| Havel's | SUT 5-0 NYLON 18"/DS-16 PROME | FDA UDI | Class II | Active |
| Havel's | SUT. 3-0 PLAIN GUT 18"/DS-24 | FDA UDI | Class II | Active |
| Havel's | SUT 5-0 PLAIN GUT 18"/DS-12 | FDA UDI | Class II | Active |
| Havel's | SUT. 3-0 SILK 18"/HS-24 | 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.