Identity
- Trade Name
- 6-ch. EMG/EP Amplifier EUDAMEDKeypoint FDA UDI
- Generic Name
- Electromyograph FDA UDI
- Device Name
- Natus Keypoint EUDAMED6-ch. Amplifier FDA UDI
- Model / Reference
- 9031C0762 EUDAMEDFDA UDI
- Description
- 6-ch. Amplifier FDA UDI
Identifiers
- Catalog Number
- 9031C0762 FDA UDI
- Primary DI / UDI-DI
- 00382830050371 EUDAMEDFDA UDI
- Basic UDI-DI
- 038283NA00166EN EUDAMED
- Direct Marketing DI
- 00382830050371 EUDAMED
- 510(k) Number
- K944547 FDA UDI
- FDA Product Code
- GWF FDA UDI
- EMDN Code
- N010199 NEUROPHYSIOLOGY DEVICES - OTHER EUDAMED
- GMDN Term
- Electromyograph FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1870 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
6-ch. EMG/EP Amplifier by Natus Manufacturing Limited — Class IIa — 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 | 038283NA00166EN | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Natus Manufacturing Limited
- EUDAMED SRN
- IE-MF-000000799
Sources (2)
- EUDAMED ac51a545-eba3-4a6c-b1d4-b5d88e39551f 61 fields · synced Jul 17, 2026
- FDA UDI 67c46deb-fe2a-487d-bcd8-c2a99327023f 35 fields · synced May 30, 2026