← Back to catalogue
Free Beta-Human Chorionic Gonadotropin Detection Kit (Chemiluminescence Immunoa…
EUDAMEDClass IVD General (EU MDR)
Ref 3013981Model 100Tests/Kit
Identity
- Trade Name
- Free Beta-Human Chorionic Gonadotropin Detection Kit (Chemiluminescence Immunoassay) EUDAMED
- Device Name
- Free Beta-Human Chorionic Gonadotropin Detection Kit (Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- 100Tests/Kit EUDAMED3013981 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794523044 EUDAMED
- Basic UDI-DI
- B-06925794523044 EUDAMED
- EMDN Code
- W0102050213 FREE BETA HCG (PRENATAL SCREENING) 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
Free Beta-Human Chorionic Gonadotropin Detection Kit (Chemiluminescence Immunoa… 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-06925794523044 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 4263b96a-2ca0-4a08-b2ef-fee3bacf6459 61 fields · synced Jul 23, 2026