Identity
- Trade Name
- Cystima Medical D-Mannose EUDAMED
- Device Name
- D-Mannose sachets EUDAMED
- Model / Reference
- 512SACHET EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-512SACHETEZ EUDAMED
- Basic UDI-DI
- B-512SACHETEZ EUDAMED
- EMDN Code
- G0499 ORALLY ADMINISTERED GASTROINTESTINAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Bulgaria 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
Cystima Medical D-Mannose 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-512SACHETEZ | Class IIa | Active |
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Manufacturer
- Manufacturer
- PK Benelux BV
- EUDAMED SRN
- NL-MF-000006672
Sources (1)
- EUDAMED 7f85ea75-500a-4884-80cb-cc428c0854e2 61 fields · synced Jun 18, 2026