Identity
- Trade Name
- QBC Capillary Centrifuge EUDAMEDQBC Diagnostics FDA UDI
- Generic Name
- Microhaematocrit centrifuge IVD FDA UDI
- Device Name
- QBC Capillary Centrifuge EUDAMEDQBC Centrifuge - Capillary Tube Centrifuge FDA UDI
- Model / Reference
- 425740 EUDAMEDFDA UDI
- Description
- QBC Centrifuge - Capillary Tube Centrifuge FDA UDI
Identifiers
- Catalog Number
- 425740 FDA UDI
- Primary DI / UDI-DI
- 00858092006031 EUDAMEDFDA UDI
- Basic UDI-DI
- 0858092006DDCCXZ EUDAMED
- Direct Marketing DI
- 00858092006031 EUDAMED
- FDA Product Code
- GKG FDA UDI
- EMDN Code
- W02069003 CENTRIFUGES EUDAMED
- GMDN Term
- Microhaematocrit centrifuge IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 864.6400 FDA UDI
- Market of Registration
- Northern Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: General-purpose centrifuge IVD
QBC Capillary Centrifuge by Drucker Diagnostics — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose centrifuge IVD.
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- cence — HUNAN XIANG YI LABORATORY INSTRUMENT DEVELOPMENT CO.,LTD. · Class A
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 0858092006DDCCXZ | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Drucker Diagnostics
- EUDAMED SRN
- US-MF-000031517
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 4da0a1d0-a24d-4c0a-9041-825350183eb1 61 fields · synced Jul 28, 2026
- FDA UDI ef65c50a-66bc-46c4-aec5-d89f4860478b 34 fields · synced May 30, 2026