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Procalcitonin (PCT) Quantitative Test Cassette (Quantum Dot Fluorescence Immuno…
EUDAMEDClass IVD General (EU MDR)
Ref GKPD060Model 25 tests/kit
Identity
- Trade Name
- Procalcitonin (PCT) Quantitative Test Cassette (Quantum Dot Fluorescence Immunochromatography) EUDAMED
- Device Name
- Procalcitonin (PCT) Quantitative Test Cassette (Quantum Dot Fluorescence Immunochromatography) EUDAMED
- Model / Reference
- 25 tests/kit EUDAMEDGKPD060 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977698403113 EUDAMED
- Basic UDI-DI
- B-06977698403113 EUDAMED
- EMDN Code
- W0102069013 PROCALCITONIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Procalcitonin (PCT) Quantitative Test Cassette (Quantum Dot Fluorescence Immuno… by Dezhou Guoke Medical Technology Co., Ltd. — Class IVD General — IVDD…
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06977698403113 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Dezhou Guoke Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000044128
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED 53aebff3-efed-45c9-8081-dfaf747b7e61 61 fields · synced Oct 6, 2026