Identity
- Trade Name
- Natus FDA UDI
- Generic Name
- Electromyograph FDA UDI
- Device Name
- RS10 Comfort Probe Kit EUDAMEDWR50 Comfort Plus Probe FDA UDI
- Model / Reference
- 515-016400 EUDAMEDFDA UDI
- Description
- WR50 Comfort Plus Probe FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00382830037280 EUDAMEDFDA UDI
- Basic UDI-DI
- 00382830058803E2 EUDAMED
- 510(k) Number
- K112052 FDA UDI
- FDA Product Code
- IKN 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
- 890.1375 FDA UDI
- Market of Registration
- France 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
RS10 Comfort Probe Kit by Natus Neurology Incorporated — 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 | 00382830058803E2 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 488f1ea2-4117-4f9e-9c98-2cde33bea2c7 61 fields · synced Jun 18, 2026
- FDA UDI 1729c7ea-4d96-4532-927b-07b8c6ea843f 34 fields · synced May 29, 2026