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Human Epididymis Protein 4 (HE4) Assay Reagent Kit (CMIA)
EUDAMEDClass IVD General (EU MDR)
Ref C2KA006Ref C2KH001
Identity
- Trade Name
- Human Epididymis Protein 4 (HE4) Assay Reagent Kit (CMIA) EUDAMED
- Model / Reference
- C2KA006 EUDAMEDC2KH001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971792050938 EUDAMED06976753470015 EUDAMED
- Basic UDI-DI
- B-06971792050938 EUDAMEDB-06976753470015 EUDAMED
- EMDN Code
- W0102030119 HUMAN EPIDIDYMIS PROTEIN 4 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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
Human Epididymis Protein 4 (HE4) 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-06971792050938 | 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 (2)
- EUDAMED b2ba8974-83b1-48e6-b047-14419dde381e 61 fields · synced Jul 14, 2026
- EUDAMED 27a367ef-214f-4433-8af4-b86307dd2f13 61 fields · synced May 18, 2026