Identity
- Trade Name
- N-Pulse FX EUDAMED
- Device Name
- Z12011005 EUDAMED
- Model / Reference
- N-Pulse FX EUDAMEDSNJ-UM-009-EN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800086000107 EUDAMED
- Basic UDI-DI
- 88000860NPFSRB EUDAMED
- Direct Marketing DI
- 08800086000107 EUDAMED
- EMDN Code
- Z12011005 CARBON DIOXIDE SURGICAL LASER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Lithuania EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
N-Pulse FX by Snj Co., Ltd — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 88000860NPFSRB | Class IIb | Active |
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Manufacturer
- Manufacturer
- SNJ Co., Ltd.
- EUDAMED SRN
- KR-MF-000026309
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 084b769f-e6d1-4efa-8e6f-5ca8a3802dd7 61 fields · synced Jun 18, 2026