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Sign in to claim this brandWhat Pentapharm GmbH makes
Pentapharm GmbH manufactures in vitro diagnostic devices for activated protein C resistance ratio testing, including controls and kits that use clotting methods, such as the Pefakit product line, and also produces the ROTEM DELTA thromboelastometry system for assessing hemostasis.
These devices are classified as Class II medical devices and are listed in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identification (UDI) system; the company 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 does Pentapharm GmbH make?
Pentapharm GmbH manufactures in vitro diagnostic devices for activated protein C resistance ratio testing, including controls and kits that use clotting methods such as the Pefakit product line, and also produces the ROTEM DELTA thromboelastometry system for assessing hemostasis.
Where is Pentapharm GmbH based?
Pentapharm GmbH is based in the United States, as stated in the device data under the COUNTRY field.
Which regulatory registries list Pentapharm GmbH's devices?
Pentapharm GmbH's devices are listed in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identification (UDI) system, as indicated in the LISTED IN field.
How are Pentapharm GmbH's devices classified?
Pentapharm GmbH's devices are classified as Class II medical devices, as specified in the DEVICE CLASSES field of the provided data.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
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Catalogue (3)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Pefakit | 502-02 | FDA UDI | Class II | Active |
| Pefakit | 502-22 | FDA UDI | Class II | Active |
| Rotem Delta Thromboelastometry System | K083842 | FDA 510(k) | Class II | Active |
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