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Pregnancy Associated Plasma Protein A (PAPP-A) Assay Reagent Kit (CMIA)
EUDAMEDClass IVD General (EU MDR)
Ref C2KC011Ref C2KJ004Ref "REF: USIA00000105M., USIA00000106M "
Identity
- Trade Name
- Pregnancy Associated Plasma Protein A (PAPP-A) Assay Reagent Kit (CMIA) EUDAMED
- Device Name
- Pregnancy-associated Plasma Protein A (PAPP-A) Assay Kit (Chemiluminescent Microparticle Immunoassay) EUDAMED
- Model / Reference
- C2KC011 EUDAMEDC2KJ004 EUDAMED"REF: USIA00000105M., USIA00000106M " EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971792051737 EUDAMED06976753471296 EUDAMEDD-6-102F4 EUDAMED
- Basic UDI-DI
- B-06971792051737 EUDAMEDB-06976753471296 EUDAMEDB-6-102F4 EUDAMED
- EMDN Code
- W0102050210 PREGNANCY ASSOCIATED PLASMA PROTEIN - A (DOWNS) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMEDSpain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMEDEUDAMED
Microbial Substances
No
EUDAMEDEUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Pregnancy Associated Plasma Protein A (PAPP-A) Assay Reagent Kit (CMIA) by Hangzhou Realy Tech 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-06971792051737 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Realy Tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000004716
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (4)
- EUDAMED 99923ec9-0cfb-4204-9a92-4cb5094d316c 61 fields · synced Jul 16, 2026
- EUDAMED 9ba45fe8-a884-4e85-89a3-76f2acbd3284 61 fields · synced May 18, 2026
- EUDAMED 349117ed-6c4e-41c5-bb5e-3f1b6454f593-1 61 fields · synced Jul 13, 2026
- EUDAMED 349117ed-6c4e-41c5-bb5e-3f1b6454f593-2 61 fields · synced Jul 13, 2026