← Back to catalogue
E2 Rapid Quantitative Test
EUDAMEDClass IVD General (EU MDR)
Ref 3642Model 25 servings/box
Identity
- Trade Name
- E2 Rapid Quantitative Test EUDAMED
- Device Name
- E2 Rapid Quantitative Test EUDAMED
- Model / Reference
- 25 servings/box EUDAMED3642 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977565583641 EUDAMED
- Basic UDI-DI
- B-06977565583641 EUDAMED
- EMDN Code
- W0102050103 ESTRADIOL EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
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
E2 Rapid Quantitative Test by Coei Biotech Co.Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06977565583641 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Coei Biotech Co.Ltd.
- EUDAMED SRN
- CN-MF-000049509
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 7c1f2457-0028-4851-9579-6567c0f67418 61 fields · synced Jul 14, 2026