Identity
- Trade Name
- Cystima Medical D-Man 14 s EUDAMED
- Device Name
- D-Mannose sachets EUDAMEDD-mannose Effervescent tablets EUDAMED
- Model / Reference
- 512ES EUDAMED512SE EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-512ESKN EUDAMEDD-512SEL4 EUDAMED
- Basic UDI-DI
- B-512ESKN EUDAMEDB-512SEL4 EUDAMED
- EMDN Code
- G0499 ORALLY ADMINISTERED GASTROINTESTINAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain EUDAMEDBelgium 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-Man 14 s 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-512ESKN | Class IIa | Active |
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Manufacturer
- Manufacturer
- PK Benelux BV
- EUDAMED SRN
- NL-MF-000006672
Sources (2)
- EUDAMED a7dad6b9-680c-41d4-95e6-91729adca032 61 fields · synced Jul 11, 2026
- EUDAMED 063da705-f337-40ed-82f0-d2e0da30338c 61 fields · synced May 18, 2026