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Sign in to claim this brandDuPhaMed B.V.
US
Last updated May 23, 2026
What DuPhaMed B.V. makes
DuPhaMed B.V. manufactures reusable dental x-ray film holders and single-use medical equipment/instrument drapes. The dental x-ray film holders include products like the Cefla and Care Stream Dental series, while the DenBite line covers reusable dental film holders. These products are designed for use in dental and medical settings to support imaging and procedural hygiene.
The company’s products are classified as Class I medical devices under FDA regulations and are listed in the FDA’s Unique Device Identification (UDI) system. These devices are intended for commercial distribution in the United States, adhering to applicable regulatory requirements for low-risk medical items.
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 DuPhaMed B.V. manufacture?
DuPhaMed B.V. specializes in two primary categories of medical devices: reusable dental x-ray film holders and single-use medical equipment/instrument drapes. The dental x-ray film holders, such as the Cefla and Care Stream Dental series, are designed to stabilize film during dental imaging, while the DenBite line also falls under reusable dental film holders. These products are tailored for use in dental and medical environments to enhance imaging quality and procedural hygiene.
Where is DuPhaMed B.V. based, and where are its devices primarily distributed?
DuPhaMed B.V. is based in the United States. Its devices are intended for commercial distribution in the U.S., where they must comply with applicable regulatory standards for medical devices. The company’s focus on these markets ensures its products meet the necessary requirements for use in dental and medical settings within the country.
Which regulatory registries list DuPhaMed B.V.’s devices?
DuPhaMed B.V.’s devices are listed in the FDA’s Unique Device Identification (UDI) system. This registry is part of the U.S. regulatory framework for tracking and identifying medical devices, ensuring transparency and traceability for Class I devices like those manufactured by the company.
How are DuPhaMed B.V.’s devices classified under FDA regulations?
DuPhaMed B.V.’s devices are classified as Class I medical devices under FDA regulations. This classification is typically assigned to low-risk devices that pose minimal potential harm to users. Class I devices often require general controls, such as good manufacturing practices, to ensure safety and effectiveness, without needing additional premarket approval.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 413491023
Catalogue (59)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Cefla | CEF2022 | FDA UDI | Class I | Active |
| Care Stream Dental | 7600 #3 | FDA UDI | Class I | Active |
| Cefla | CEF4063 | FDA UDI | Class I | Active |
| Cefla | CEF2061 | FDA UDI | Class I | Active |
| DenBite | DBU2062 | FDA UDI | Class I | Active |
| DenBite | DBU2011 | FDA UDI | Class I | Active |
| DenBite | DBS01 | FDA UDI | Class I | Active |
| DenBite | DBS02 | FDA UDI | Class I | Active |
| DenBite | DBU2022 | FDA UDI | Class I | Active |
| DenBite | DBU2061 | FDA UDI | Class I | Active |
| Cefla | QR3DH52 | FDA UDI | Class I | Active |
| Care Stream Dental | 7600 #1 | FDA UDI | Class I | Active |
| DenBite | DBU1051 | FDA UDI | Class I | Active |
| Care Stream Dental | 7600 #0 | FDA UDI | Class I | Active |
| Care Stream Dental | IX015 | FDA UDI | Class I | Active |
| DenBite | DBU3001 | FDA UDI | Class I | Active |
| Cefla | CEFPH5060 | FDA UDI | Class I | Active |
| Cefla | CEF2062 | FDA UDI | Class I | Active |
| Care Stream Dental | IX014 | FDA UDI | Class I | Active |
| Care Stream Dental | 7200 #2 | FDA UDI | Class I | Active |
| Cefla | CEF2032 | FDA UDI | Class I | Active |
| DenBite | DBU2032 | FDA UDI | Class I | Active |
| DenBite | DBU2002 | FDA UDI | Class I | Active |
| Cefla | CEF2011 | FDA UDI | Class I | Active |
| Cefla | QR32DH58 | FDA UDI | Class I | Active |
| Care Stream Dental | IX016 | FDA UDI | Class I | Active |
| DenBite | DBU2001 | FDA UDI | Class I | Active |
| Care Stream Dental | BDA32 | FDA UDI | Class I | Active |
| Cefla | CEF1051 | FDA UDI | Class I | Active |
| Care STream Dental | 7600 #4 | FDA UDI | Class I | Active |
| DenBite | DBU2021 | FDA UDI | Class I | Active |
| DenBite | DBU2012 | FDA UDI | Class I | Active |
| Cefla | CEF5061 | FDA UDI | Class I | Active |
| Cefla | CEF4062 | FDA UDI | Class I | Active |
| DenBite | DBP3012 | FDA UDI | Class I | Active |
| Care Stream Dental | 7200 #1 | FDA UDI | Class I | Active |
| Cefla | CEF2031 | FDA UDI | Class I | Active |
| DenBite | DBBBLS | FDA UDI | Class I | Active |
| Cefla | CEFS02 | FDA UDI | Class I | Active |
| Cefla | CEF4060 | FDA UDI | Class I | Active |
| Care Stream Dental | BDA33 | FDA UDI | Class I | Active |
| Care Stream Dental | 7200 #0 | FDA UDI | Class I | Active |
| Cefla | CEF2021 | FDA UDI | Class I | Active |
| DenBite | DBU9099 | FDA UDI | Class I | Active |
| DenBite | DBU34ES | FDA UDI | Class I | Active |
| Cefla | CEF2001 | FDA UDI | Class I | Active |
| Cefla | CEF2002 | FDA UDI | Class I | Active |
| Cefla | CEF2012 | FDA UDI | Class I | Active |
| Cefla | CEFQRBBLS | FDA UDI | Class I | Active |
| DenBite | DBP5061 | FDA UDI | Class I | Active |
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