← Back to catalogue
Guardian P2 Wireless Audio System
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref NC130002Model Wireless Audio System
by NeoCoil, LLC
Identity
- Trade Name
- Guardian P2 Wireless Audio System EUDAMED
- Device Name
- Wireless Audio System EUDAMED
- Model / Reference
- Wireless Audio System EUDAMEDNC130002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850028932230 EUDAMED
- Basic UDI-DI
- 0850028932347J EUDAMED
- EMDN Code
- Z1105018099 MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER 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
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
Guardian P2 Wireless Audio System by Neocoil, Llc — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K173409 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 0850028932347J | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- NeoCoil, LLC
- EUDAMED SRN
- US-MF-000027128
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED b077b63f-55cc-40e5-8389-f58009aee2a3 61 fields · synced Jul 8, 2026
- FDA 510(k) K173409 1 fields · synced May 18, 2026