← Back to catalogue
Estromineral
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref 822011-2HModel 820011-x
by PRIMA Lab SA
Identity
- Trade Name
- Estromineral EUDAMED
- Device Name
- Estromineral TEST MENOPAUSA EUDAMED
- Model / Reference
- 820011-x EUDAMED822011-2H EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-822011P8 EUDAMED
- Basic UDI-DI
- B-822011P8 EUDAMED
- EMDN Code
- W0102050104 FOLLICLE STIMULATING HORMONE EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
No
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Estromineral by PRIMA Lab SA — Class IVD devices for self-testing — 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-822011P8 | Class IVD devices for self-testing | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- PRIMA Lab SA
- EUDAMED SRN
- CH-MF-000034473
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED 2c444c92-6d6e-4b12-b994-4374fb054c7c 61 fields · synced Jun 19, 2026