Identity
- Trade Name
- LB&D EUDAMED
- Device Name
- LB&D Hypertonic Nasal Spray 20ml EUDAMED
- Model / Reference
- 312714 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-312714N5 EUDAMED
- Basic UDI-DI
- B-312714N5 EUDAMED
- EMDN Code
- Q030103 NASAL IRRIGATION SOLUTIONS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Lb&D 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-312714N5 | Class I | Active |
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Manufacturer
- Manufacturer
- PK Benelux BV
- EUDAMED SRN
- NL-MF-000006672
Sources (1)
- EUDAMED 82c2f7dd-99ad-4c95-aed4-8e3855afe640 61 fields · synced Jun 18, 2026