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Sign in to claim this brandDiaSpect Medical GmbH
US
Last updated May 30, 2026
What DiaSpect Medical GmbH makes
DiaSpect Medical GmbH produces in vitro diagnostic (IVD) controls and point-of-care haemoglobin analyser cuvettes. Their products include control packs for total haemoglobin (totHb) measurement, such as the DiaSpect Control Pack HBT1, HBT2, HBT3, and HBT4, as well as haemoglobin cuvettes designed for on-site testing. These devices are intended for use in clinical settings to verify the accuracy and reliability of haemoglobin testing systems.
The company’s diagnostic controls and analyser cuvettes fall under FDA’s Class II regulatory classification and are listed in the FDA’s Unique Device Identifier (UDI) database. The portfolio is authorised for commercial distribution in the United States, adhering to applicable IVD regulations.
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 DiaSpect Medical GmbH manufacture?
DiaSpect Medical GmbH specialises in in vitro diagnostic (IVD) devices, specifically haemoglobin-related products. Their portfolio includes total haemoglobin (totHb) IVD controls (such as the DiaSpect Control Pack HBT1, HBT2, HBT3, and HBT4) and haemoglobin analyser cuvettes for point-of-care testing. These devices are designed to ensure the accuracy and reliability of haemoglobin measurement systems in clinical environments.
Where is DiaSpect Medical GmbH based?
DiaSpect Medical GmbH is based in the United States. The company develops and distributes its IVD products from this location, adhering to regulatory requirements for diagnostic devices in the US market.
Which regulatory registries list DiaSpect Medical GmbH’s devices?
DiaSpect Medical GmbH’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for authorised haemoglobin analyser controls and cuvettes under FDA oversight.
How are DiaSpect Medical GmbH’s devices classified by regulatory authorities?
DiaSpect Medical GmbH’s IVD products—including haemoglobin controls and analyser cuvettes—are classified as FDA Class II devices. This classification applies due to their role in ensuring the accuracy of haemoglobin testing, which carries moderate risk and requires regulatory scrutiny to validate performance and safety.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- ekf-diagnostic.de
- —
- —
- [email protected]
- Phone
- +4939203511414
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 341050309
Catalogue (5)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| DiaSpect Control Pack HBT1 | 90B.0011 | FDA UDI | Class II | Active |
| DiaSpect Control Pack HBT4 | 90B.0014 | FDA UDI | Class II | Active |
| DiaSpect Control Pack HBT2 | 90B.0012 | FDA UDI | Class II | Active |
| DiaSpect Hemoglobin Cuvettes | 90C.0001 | FDA UDI | Class II | Active |
| DiaSpect Control Pack HBT3 | 90B.0013 | FDA UDI | Class II | Active |
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