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Prolactin (PRL) Quantitative Test Cassette (Quantum Dot Fluorescence Immunochro…
EUDAMEDClass IVD General (EU MDR)
Ref GKPD062Model 25 tests/kit
Identity
- Trade Name
- Prolactin (PRL) Quantitative Test Cassette (Quantum Dot Fluorescence Immunochromatography) EUDAMED
- Device Name
- Prolactin (PRL) Quantitative Test Cassette (Quantum Dot Fluorescence Immunochromatography) EUDAMED
- Model / Reference
- 25 tests/kit EUDAMEDGKPD062 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977698403229 EUDAMED
- Basic UDI-DI
- B-06977698403229 EUDAMED
- EMDN Code
- W0102160999 INDIVIDUAL AND SPECIFIC HORMONES/PROTEINS RT & POC - OTHER 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
Prolactin (PRL) Quantitative Test Cassette (Quantum Dot Fluorescence Immunochro… 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-06977698403229 | 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 a4678181-0ac1-475b-85d3-73bc1b6998d3 61 fields · synced Jul 12, 2026