Identity
- Trade Name
- Flex Arm with Clamp EUDAMEDNatus FDA UDI
- Generic Name
- Electromyograph FDA UDI
- Device Name
- Keypoint Class 1 Accessories (Hardware) EUDAMEDFlex Arm with Clamp, 40 cm FDA UDI
- Model / Reference
- 9033B0761 EUDAMEDFDA UDI
- Description
- Flex Arm with Clamp, 40 cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00382830049436 EUDAMEDFDA UDI
- Basic UDI-DI
- 038283NA00081ED EUDAMED
- 510(k) Number
- K944547 FDA UDI
- FDA Product Code
- GWF FDA UDI
- EMDN Code
- Z12100480 ELECTROMYOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Electromyograph FDA UDI
Classification
- Device Class
- Class I 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Flex Arm with Clamp by Natus Manufacturing Limited — Class I — 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 | 038283NA00081ED | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Natus Manufacturing Limited
- EUDAMED SRN
- IE-MF-000000799
Sources (2)
- EUDAMED 7aed9fb0-7a43-4e9d-a6e1-ce40a5414122 61 fields · synced Jul 13, 2026
- FDA UDI f0b50ce2-7f9d-4755-8140-150e350aa79a 34 fields · synced May 29, 2026