Identity
- Trade Name
- LTK170 - NYXY PRO EUDAMED
- Device Name
- AP7005A EUDAMED
- Model / Reference
- LTK170 - NYXY PRO EUDAMEDAP7005A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08057018716449 EUDAMED
- Basic UDI-DI
- B-08057018716449 EUDAMED
- EMDN Code
- Z12159002 AEROSOL EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Ltk170 - Nyxy Pro by 3A HEALTH CARE S.r.l. — 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-08057018716449 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- 3A HEALTH CARE S.r.l.
- EUDAMED SRN
- IT-MF-000009298
Sources (1)
- EUDAMED baa4f784-008c-41f5-a6d0-5c9dad217cd9 61 fields · synced Jun 18, 2026