Identity
- Trade Name
- ABC Bacterial Vaginosis 5x7 ml EUDAMED
- Device Name
- Bacterial Vaginosis 5x7 ml EUDAMED
- Model / Reference
- 954854 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-954854SW EUDAMED
- Basic UDI-DI
- B-954854SW EUDAMED
- EMDN Code
- U0803 VAGINAL DEVICES IN THE FORM OF SOLUTIONS/CREAMS/OVA/TABLETS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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
ABC Bacterial Vaginosis 5x7 ml by PK Benelux BV — 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-954854SW | Class IIa | Active |
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Manufacturer
- Manufacturer
- PK Benelux BV
- EUDAMED SRN
- NL-MF-000006672
Sources (1)
- EUDAMED bda451d6-820d-4c97-900d-9dfdabc81d0e 61 fields · synced Jul 17, 2026