Identity
- Trade Name
- Apoliva Intim Glidmedel 100 ml EUDAMED
- Device Name
- Lubricant EUDAMED
- Model / Reference
- 350221/426001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06420615711032 EUDAMED
- Basic UDI-DI
- 642061571350221AZ EUDAMED
- EMDN Code
- U0803 VAGINAL DEVICES IN THE FORM OF SOLUTIONS/CREAMS/OVA/TABLETS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Sweden 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
Apoliva Intim Glidmedel 100 ml 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 | 642061571350221AZ | Class IIb | Active |
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Manufacturer
- Manufacturer
- Galena Pharma Oy
- EUDAMED SRN
- FI-MF-000000588
Sources (1)
- EUDAMED ebf0690e-70fa-4431-9689-350f2883fb04 61 fields · synced Jul 31, 2026