Identity
- Trade Name
- Hydrogel EUDAMED
- Device Name
- Hydrogel nasenspray 20 ml EUDAMED
- Model / Reference
- 200000536 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-200000536DM EUDAMED
- Basic UDI-DI
- B-200000536DM EUDAMED
- EMDN Code
- Q030103 NASAL IRRIGATION SOLUTIONS EUDAMED
Classification
- Device Class
- Class I 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
Hydrogel by PK Benelux BV — Class I — 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-200000536DM | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- PK Benelux BV
- EUDAMED SRN
- NL-MF-000006672
Sources (1)
- EUDAMED fb6a8428-3f1c-4452-ae76-7bb3faf7d189 61 fields · synced Sep 17, 2026