Identity
- Trade Name
- Femisan Balance emätingeeli 7x5ml EUDAMED
- Device Name
- BV-gel (Bacterial vaginosis vaginal gel) EUDAMED
- Model / Reference
- 725114 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06420615710769 EUDAMED
- Basic UDI-DI
- 642061571350169BQ EUDAMED
- EMDN Code
- U0803 VAGINAL DEVICES IN THE FORM OF SOLUTIONS/CREAMS/OVA/TABLETS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Femisan Balance emätingeeli 7x5ml by Galena Pharma Oy — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 642061571350169BQ | Class IIb | Active |
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Manufacturer
- Manufacturer
- Galena Pharma Oy
- EUDAMED SRN
- FI-MF-000000588
Sources (1)
- EUDAMED 9c3cd553-65bb-4068-9d43-c5286687f2ec 61 fields · synced Jul 31, 2026