Identity
- Trade Name
- Cystima Medical D-Man 30 s EUDAMED
- Device Name
- D-Mannose sachets EUDAMED
- Model / Reference
- 512GMES EUDAMED512GM EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-512GMESAM EUDAMEDD-512GMKG EUDAMED
- Basic UDI-DI
- B-512GMESAM EUDAMEDB-512GMKG EUDAMED
- EMDN Code
- G0499 ORALLY ADMINISTERED GASTROINTESTINAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain EUDAMEDNetherlands 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 30 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-512GMESAM | Class IIa | Active |
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Manufacturer
- Manufacturer
- PK Benelux BV
- EUDAMED SRN
- NL-MF-000006672
Sources (2)
- EUDAMED e58d8f49-e1f1-4ba3-b2c3-9885f1a94db2 61 fields · synced Jul 30, 2026
- EUDAMED fdcf2285-32d7-423d-9798-cb8e2c5688b5 61 fields · synced May 19, 2026