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Guardian S2 Wireless Audio System
EUDAMEDClass I (EU MDR)
Ref NC130000Model Wireless Audio System
by NeoCoil, LLC
Identity
- Trade Name
- Guardian S2 Wireless Audio System EUDAMED
- Device Name
- Wireless Audio System EUDAMED
- Model / Reference
- Wireless Audio System EUDAMEDNC130000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850028932223 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 S2 Wireless Audio System by Neocoil, Llc — Class I — 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 | 0850028932347J | Class I | Active |
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Manufacturer
- Manufacturer
- NeoCoil, LLC
- EUDAMED SRN
- US-MF-000027128
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED ae740a8c-ab3a-4893-b0ae-7567875d4232 61 fields · synced Jun 19, 2026