Identity
- Trade Name
- Focus Main Unit EUDAMEDKeypoint FDA UDI
- Generic Name
- Electromyograph FDA UDI
- Device Name
- Natus Keypoint EUDAMEDKeypoint Focus Main Unit FDA UDI
- Model / Reference
- 9033G0704 EUDAMEDFDA UDI
- Description
- Keypoint Focus Main Unit FDA UDI
Identifiers
- Catalog Number
- 9033G0704 FDA UDI
- Primary DI / UDI-DI
- 00382830049450 EUDAMEDFDA UDI
- Basic UDI-DI
- 038283NA00166EN EUDAMED
- Direct Marketing DI
- 00382830049450 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
Focus Main Unit 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 0da3b59a-a342-4cda-8768-66d672657ba4 61 fields · synced Jul 12, 2026
- FDA UDI 94574ba1-a268-4652-83e7-5e1c8c7ef834 35 fields · synced May 30, 2026