Identity
- Trade Name
- YA Emätingeeli 7x5ml EUDAMED
- Device Name
- YA Emätingeeli EUDAMEDBV-gel (Bacterial vaginosis vaginal gel) EUDAMED
- Model / Reference
- 9920431 EUDAMED422005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06418879155310 EUDAMED06420615710752 EUDAMED
- Basic UDI-DI
- B-06418879155310 EUDAMED642061571350169BQ EUDAMED
- EMDN Code
- U0803 VAGINAL DEVICES IN THE FORM OF SOLUTIONS/CREAMS/OVA/TABLETS EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass 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
YA Emätingeeli 7x5ml by Galena Pharma Oy — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06418879155310 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06418879155310 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Galena Pharma Oy
- EUDAMED SRN
- FI-MF-000000588
Sources (2)
- EUDAMED 30ffab75-2460-4038-b978-453b0944a81e 61 fields · synced Aug 4, 2026
- EUDAMED a19a498d-0d5d-4ad3-a8d7-7c7055baa874 61 fields · synced May 18, 2026