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Sign in to claim this brandPANPAC MEDICAL CORPORATION
US
Last updated May 24, 2026
What PANPAC MEDICAL CORPORATION makes
PanPac Medical Corporation manufactures devices for gynecological procedures, including uterine manipulators, hysteroscopy catheters, pessaries, and biopsy tools. Their portfolio includes inflatable pessaries for pelvic organ prolapse, cervical cones for sonohysterography, and suction curettes for endometrial sampling. The company also produces vaginal dilators and catheters for Bartholin gland interventions, as well as disposable fitting sets for pessary applications.
These devices are classified under Class II regulatory categories in the US and are listed in the FDA’s 510(k) and UDI registries. The manufacturer operates from the United States, adhering to US medical device compliance standards.
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 PanPac Medical Corporation manufacture?
PanPac Medical Corporation specializes in gynecological medical devices. Their portfolio includes catheters for hysteroscopy and endometrial biopsy (such as the Bellota sonohysterography catheter), uterine manipulators and injectors (like the PANPAC UTERINE MANIPULATOR INJECTOR), pessaries (including inflatable and disposable fitting sets), suction curettes for endometrial sampling, vaginal dilators, and catheters for Bartholin gland procedures. These devices are designed to assist in diagnostic and therapeutic gynecological interventions.
Where is PanPac Medical Corporation based, and what does that mean for their regulatory compliance?
PanPac Medical Corporation is based in the United States. Since they operate within the US, their devices must comply with US medical device regulations, including those governed by the FDA. The company’s products are classified under Class II devices, which typically require premarket notification (510(k)) clearance before commercial distribution in the US. This classification reflects a moderate level of risk, requiring specific controls to ensure safety and effectiveness.
Which regulatory registries list PanPac Medical Corporation’s devices?
PanPac Medical Corporation’s devices are listed in the FDA’s 510(k) registry and the FDA’s Unique Device Identifier (UDI) system. The 510(k) registry documents premarket submissions for Class II devices, while the UDI system ensures standardized identification and traceability of medical devices in the US marketplace. These registries help healthcare providers, regulators, and distributors verify the authorized status of their products.
How are PanPac Medical Corporation’s devices classified in the US regulatory system?
PanPac Medical Corporation’s devices fall under Class II classification in the US regulatory framework. This classification is assigned based on the level of risk associated with the device—Class II devices pose moderate risks and require special controls (such as performance standards or post-market surveillance) in addition to general controls. Unlike Class I devices (low risk), they must undergo a 510(k) premarket notification process to demonstrate substantial equivalence to a legally marketed predicate device before being authorized for sale.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- panpac.com.tw
- —
- —
- [email protected]
- Phone
- +866286472242
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 657528899
Catalogue (14)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| The O.R. Company LLC | UMI 4.5C-D | FDA UDI | Class II | Active |
| The O.R. Company LLC | UMI 4.5KC-D | FDA UDI | Class II | Active |
| Panpac Flexi Shelf Pessary | K173351 | FDA 510(k) | Class II | Active |
| Panpac Uterine Manipulator Injector, Model Umi 4.5 | K092980 | FDA 510(k) | Class II | Active |
| Bellota Sonohysterography Catheter With Cervical Cone, Bellota Sonohysterography Catheter Without Cervical Cone | K102898 | FDA 510(k) | Class II | Active |
| Panpac Hsg Catheter Set | K092983 | FDA 510(k) | Class II | Active |
| Panpac Disposable Pessary Fitting Set | K153422 | FDA 510(k) | Class II | Active |
| Panpac Inflatable Docut Pessary | K132670 | FDA 510(k) | Class II | Active |
| The Panpac Suction Curette | K092982 | FDA 510(k) | Class II | Active |
| Panpac Uterine Inector, Model Ui-4.0, Ui-2.0 | K092984 | FDA 510(k) | Class II | Active |
| Panpac Word/Bartholin Catheter | K130087 | FDA 510(k) | Class II | Active |
| Panpac Vaginal Dilators | K130273 | FDA 510(k) | Class II | Active |
| Panpac Vaginal Pessary | K092981 | FDA 510(k) | Class II | Active |
| Panpac Disposable Vacuum Curettes | K161106 | FDA 510(k) | Class II | Active |
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