Identity
- Trade Name
- EDX 2 channel Amplifier EUDAMEDNatus FDA UDI
- Generic Name
- Electromyograph FDA UDI
- Device Name
- Nicolet EDX EUDAMEDEDX 2 channel Amplifier 0160 FDA UDI
- Model / Reference
- 515-016000 EUDAMEDFDA UDI
- Description
- EDX 2 channel Amplifier 0160 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00382830032155 EUDAMED00382830037341 FDA UDI
- Basic UDI-DI
- 038283NA00151E9 EUDAMED
- Direct Marketing DI
- 00382830032155 EUDAMED
- 510(k) Number
- K112052 FDA UDI
- FDA Product Code
- IKN FDA UDI
- EMDN Code
- Z12100401 ELECTROMYOGRAPHS EUDAMED
- GMDN Term
- Electromyograph FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 890.1375 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
EDX 2 channel Amplifier by Natus Neurology Incorporated — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 038283NA00151E9 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Natus Neurology Incorporated
- EUDAMED SRN
- US-MF-000004246
- Authorised Representative
- Natus Manufacturing Ltd IE-AR-000000884
Sources (2)
- EUDAMED 66cff1e0-2483-4b34-9bcc-000db043c485 61 fields · synced Oct 6, 2026
- FDA UDI 70dea409-da06-4b63-922a-26d765f7aa6f 34 fields · synced May 30, 2026