Identity
- Trade Name
- PRO GYNO balance HR, BA EUDAMED
- Device Name
- Lasjt Gyn Capsule Vaginali EUDAMED
- Model / Reference
- FTP050 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-FTP050EL EUDAMED
- Basic UDI-DI
- B-FTP050EL EUDAMED
- EMDN Code
- U0803 VAGINAL DEVICES IN THE FORM OF SOLUTIONS/CREAMS/OVA/TABLETS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Croatia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
PRO GYNO balance HR, BA by Labomar S.p.A. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-FTP050EL | Class IIa | Active |
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Manufacturer
- Manufacturer
- Labomar S.p.A.
- EUDAMED SRN
- IT-MF-000007965
Sources (1)
- EUDAMED c37e9a86-93b6-4270-b222-1d749db1d70d 61 fields · synced Jun 18, 2026