Identity
- Trade Name
- careHPV Test Luminometer EUDAMED
- Device Name
- careHPV Test Luminometer EUDAMED
- Model / Reference
- 9001773 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04053228048015 EUDAMED
- Basic UDI-DI
- 4053228ICARELUM0000000128 EUDAMED
- Direct Marketing DI
- 04053228048015 EUDAMED
- EMDN Code
- W02050199 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER EUDAMED
Classification
- Device Class
- Class A 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
careHPV Test Luminometer by QIAGEN GmbH — 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 | 4053228ICARELUM0000000128 | Class A | Active |
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Manufacturer
- Manufacturer
- QIAGEN GmbH
- EUDAMED SRN
- DE-MF-000004949
Sources (1)
- EUDAMED 62c973f6-e784-4bd7-b4f4-84fcc1885d0c 61 fields · synced Jun 19, 2026