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Hybrid Capture System Microplate Heater 1
EUDAMEDClass A (EU MDR)
Ref 6000-1240U
Identity
- Trade Name
- Hybrid Capture System Microplate Heater 1 EUDAMED
- Device Name
- Hybrid Capture System Microplate Heater 1 EUDAMED
- Model / Reference
- 6000-1240U EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04053228028024 EUDAMED
- Basic UDI-DI
- 4053228IHCSHEATER000001SJ EUDAMED
- EMDN Code
- W02079012 LABORATORY HOTPLATES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
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
Hybrid Capture System Microplate Heater 1 by QIAGEN Sciences LLC — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 4053228IHCSHEATER000001SJ | Class A | Active |
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Manufacturer
- Manufacturer
- QIAGEN Sciences LLC
- EUDAMED SRN
- US-MF-000014502
- Authorised Representative
- QIAGEN GmbH DE-AR-000004971
Sources (1)
- EUDAMED b7162d64-81fc-44af-9637-02bb647a5408 61 fields · synced Jun 18, 2026