← Back to catalogue
E2 Assay kit CLIA
EUDAMEDClass IVD General (EU MDR)
Ref SUPM062072Ref SUPM062036
Identity
- Trade Name
- E2 Assay kit CLIA EUDAMED
- Device Name
- E2 Assay kit CLIA EUDAMED
- Model / Reference
- SUPM062072 EUDAMEDSUPM062036 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974521004059 EUDAMED06974521004042 EUDAMED
- Basic UDI-DI
- B-06974521004059 EUDAMEDB-06974521004042 EUDAMED
- EMDN Code
- W0102050103 ESTRADIOL EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Ireland 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 Assay kit CLIA by Shenzhen Superbio Technology 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-06974521004059 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Superbio Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000024149
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (2)
- EUDAMED 77f325e7-dedc-479e-82eb-406f098c6387 61 fields · synced Jul 27, 2026
- EUDAMED e8ee68a7-0678-46b4-b890-47a96306120b 61 fields · synced May 16, 2026