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Sign in to claim this brandMedSafety Solutions
United States·US-MF-000008537
Last updated September 18, 2026
About
MedSafety Solutions provides KwikVial™ products to pharmacy clinicians and the healthcare community to help deliver care to patients safely and efficiently.
From the manufacturer's own website. Source
What MedSafety Solutions makes
MedSafety Solutions manufactures non-standardized oral syringes and basic intravenous administration sets designed for noninvasive use. Their primary product, the KwikDose Oral Dispenser, is intended for oral medication delivery, while they also produce female Luer Lock caps compatible with these systems.
The company’s devices are classified as Class I or Class II under regulatory frameworks, with listings in the EU’s EUDAMED database and the FDA’s Unique Device Identifier (UDI) system. The manufacturer is based in 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 MedSafety Solutions manufacture?
MedSafety Solutions specializes in two primary device categories: non-standardized oral syringes (such as the KwikDose Oral Dispenser) and basic intravenous administration sets designed for noninvasive use. These devices are engineered to simplify medication delivery in clinical settings, with a focus on oral administration systems and compatible accessories like female Luer Lock caps.
Where is MedSafety Solutions based, and how does that affect its regulatory compliance?
MedSafety Solutions is based in the United States. Since the company’s devices are listed in both the EU’s EUDAMED database and the FDA’s Unique Device Identifier (UDI) system, its regulatory compliance spans both U.S. and EU markets. This dual-listing reflects adherence to respective frameworks, though individual device authorization depends on the regulatory body’s assessment of each product’s classification and risk.
Which regulatory registries list MedSafety Solutions’ devices, and why are these important?
MedSafety Solutions’ devices are listed in EUDAMED (the EU’s medical device registry) and the FDA’s UDI system (Unique Device Identifier database). These registries ensure transparency and traceability of medical devices in their respective markets. EUDAMED is critical for EU compliance, while the FDA’s UDI system supports post-market surveillance and recall tracking in the U.S., helping regulators and healthcare providers verify device authenticity and safety.
How are MedSafety Solutions’ devices classified under regulatory frameworks, and what does this mean?
MedSafety Solutions’ devices are classified as Class I or Class II under regulatory frameworks. Classification determines the level of scrutiny and regulatory controls applied. Class I devices (e.g., some oral syringes) generally pose minimal risk and require basic compliance, while Class II devices (e.g., certain intravenous administration sets) involve additional premarket evaluations to ensure safety and performance. The classification is based on factors like intended use, risk potential, and design complexity as defined by the FDA and EU regulations.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 11233 E. Caley Ave., Centennial, Colorado, United States
- Website
- www.medsafetysolutions.com
- —
- [email protected]
- Phone
- +1 303 901 4619
- PRRC Contact
- Richard Weiskopf
- EUDAMED SRN
- US-MF-000008537
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (37)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| KwikDose Oral Dispenser | 74210 | FDA UDI | Class I | Active |
| KwikDose Oral Dispenser | 84210 | FDA UDI | Class I | Active |
| KwikDose Oral Dispenser | 7500 | FDA UDI | Class I | Active |
| KwikDose Oral Dispenser | 7110 | FDA UDI | Class I | Active |
| KwikDose Oral Dispenser | 84205 | FDA UDI | Class I | Active |
| Female Luer Lock Cap | 75309 | FDA UDI | Class II | Active |
| KwikDose Oral Dispenser | 8500 | FDA UDI | Class I | Active |
| KwikDose Oral Dispenser | 74205 | FDA UDI | Class I | Active |
| KwikDose Oral Dispenser | 7103 | FDA UDI | Class I | Active |
| KwikDose Oral Dispenser | 74201 | FDA UDI | Class I | Active |
| KwikDose Oral Dispenser | 8503 | FDA UDI | Class I | Active |
| KwikDose Oral Dispenser | 8100 | FDA UDI | Class I | Active |
| KwikDose Oral Dispenser | 8110 | FDA UDI | Class I | Active |
| KwikDose Oral Dispenser | 8505 | FDA UDI | Class I | Active |
| KwikDose Oral Dispenser | 7503 | FDA UDI | Class I | Active |
| KwikDose Oral Dispenser | 7120 | FDA UDI | Class I | Active |
| KwikDose Oral Dispenser | 7100 | FDA UDI | Class I | Active |
| KwikDose Oral Dispenser | 7501 | FDA UDI | Class I | Active |
| KwikDose Oral Dispenser | 8120 | FDA UDI | Class I | Active |
| KwikDose Oral Dispenser | 8101 | FDA UDI | Class I | Active |
| KwikDose Oral Dispenser | 84203 | FDA UDI | Class I | Active |
| KwikDose Oral Dispenser | 7505 | FDA UDI | Class I | Active |
| KwikDose Oral Dispenser | 8510 | FDA UDI | Class I | Active |
| KwikDose Oral Dispenser Cap | 50300 | FDA UDI | Class I | Active |
| KwikDose Oral Dispenser | 8105 | FDA UDI | Class I | Active |
| KwikDose Oral Dispenser | 7101 | FDA UDI | Class I | Active |
| KwikDose Oral Dispenser | 74203 | FDA UDI | Class I | Active |
| KwikDose Oral Dispenser | 7510 | FDA UDI | Class I | Active |
| KwikDose Oral Dispenser | 8103 | FDA UDI | Class I | Active |
| KwikDose Oral Dispenser | 7105 | FDA UDI | Class I | Active |
| KwikDose Oral Dispenser | 84201 | FDA UDI | Class I | Active |
| KwikDose Oral Dispenser | 8501 | FDA UDI | Class I | Active |
| 16-Gauge 1.5" Green TwoFer Huber-Tipped Vented Needle | 19003 | EUDAMEDFDA UDI | Class I | Active |
| Female Luer Lock Cap | K200425 | FDA 510(k) | Class II | Active |
| 15ml KwikVial Oral Liquid Container | 30015 | EUDAMEDFDA UDI | Class I | Active |
| 30ml KwikVial Oral Liquid Container | 30030 | EUDAMEDFDA UDI | Class I | Active |
| 16-Gauge 1.0" Purple TwoFer Huber-Tipped Vented Needle | 16004 | EUDAMEDFDA UDI | Class I | Active |
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