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Grass® MR Conditional/CT Array Cup Electrodes
EUDAMEDFDA UDIClass I (EU MDR)
Ref MRARR27-59Model MRSIN1-39;MRSIN2-39;MRSIN3-39;MRSIN1-59;MRSIN2-59;MRSIN3-59;MRARR27-59;MRARR25-39;MRARR25-59;MRARR23-39;MRARR23-59;MRARR30-39;MRARR30-59
Identity
- Trade Name
- Grass® MR Conditional/CT Array Cup Electrodes EUDAMEDGrass® MR Conditional/CT Cup Electrodes FDA UDI
- Generic Name
- Analytical scalp electrode, single-use FDA UDI
- Device Name
- Grass® MR Conditional/CT Cup Electrodes EUDAMEDGrass® MR Conditional/CT Cup Electrodes Array, 27 leads, 3 arrays, 1.5M FDA UDI
- Model / Reference
- MRSIN1-39;MRSIN2-39;MRSIN3-39;MRSIN1-59;MRSIN2-59;MRSIN3-59;MRARR27-59;MRARR25-39;MRARR25-59;MRARR23-39;MRARR23-59;MRARR30-39;MRARR30-59 EUDAMEDMRARR27-59 EUDAMEDFDA UDI
- Description
- Grass® MR Conditional/CT Cup Electrodes Array, 27 leads, 3 arrays, 1.5M FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00382830051255 EUDAMEDFDA UDI
- Basic UDI-DI
- 038283NA00170ED EUDAMED
- 510(k) Number
- K242346 FDA UDI
- FDA Product Code
- GXY FDA UDI
- EMDN Code
- N010101 ELECTROMYOGRAPHIC ELECTRODES EUDAMED
- GMDN Term
- Analytical scalp electrode, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1320 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
Yes
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Grass® MR Conditional/CT Array Cup Electrodes by Natus Manufacturing Limited — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 038283NA00170ED | 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 fe6f7cc5-4de2-4598-b340-f4ec5c37e0c8 61 fields · synced Jul 9, 2026
- FDA UDI c1384f3a-70b2-4d29-8b8c-efb4257de2c8 34 fields · synced May 30, 2026