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Human Pregnancy Associated Plasma Protein A Detection Kit (Chemiluminescence Im…
EUDAMEDClass IVD General (EU MDR)
Ref 3010696Model 100Tests/KitRef 3013743Model 2×50Tests/Kit
Identity
- Trade Name
- Human Pregnancy Associated Plasma Protein A Detection Kit (Chemiluminescence Immunoassay) EUDAMED
- Device Name
- Human Pregnancy Associated Plasma Protein A Detection Kit (Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- 100Tests/Kit EUDAMED3010696 EUDAMED2×50Tests/Kit EUDAMED3013743 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794518538 EUDAMED06942202224171 EUDAMED
- Basic UDI-DI
- B-06925794518538 EUDAMEDB-06942202224171 EUDAMED
- EMDN Code
- W0102050210 PREGNANCY ASSOCIATED PLASMA PROTEIN - A (DOWNS) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
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
Human Pregnancy Associated Plasma Protein A Detection Kit (Chemiluminescence Im… by Dirui Industrial Co., Ltd — Class IVD General — IVDD — listed in EUDAMED
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-06925794518538 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 3538751a-eba4-4e81-9b51-24e0026f8a01 61 fields · synced Jul 20, 2026
- EUDAMED d7a5ea22-3301-4c40-a4af-bfd524499955 61 fields · synced May 19, 2026