Identity
- Trade Name
- Regresil 30 ml CZ, SK EUDAMED
- Device Name
- CREMAGEL VAGINALE SILAUT EUDAMED
- Model / Reference
- FTP021 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-FTP021_2HT EUDAMED
- Basic UDI-DI
- B-FTP021_2HT EUDAMED
- EMDN Code
- U0803 VAGINAL DEVICES IN THE FORM OF SOLUTIONS/CREAMS/OVA/TABLETS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Czechia 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
Regresil 30 ml CZ, SK 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-FTP021_2HT | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Labomar S.p.A.
- EUDAMED SRN
- IT-MF-000007965
Sources (1)
- EUDAMED 415a06aa-62ce-43a4-a261-d4b5c1035bb2 61 fields · synced Jul 9, 2026