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HydroCel Geodesic Sensor Net - HCGSN 130
FDA UDIEUDAMEDClass II (US FDA UDI)
by Magstim Inc.
Identity
- Trade Name
- HydroCel Geodesic Sensor Net - HCGSN 130 FDA UDI
- Generic Name
- Electroencephalograph FDA UDI
- Model / Reference
- 473xxxx FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850033571035 FDA UDI
- 510(k) Number
- K131882 FDA UDI
- FDA Product Code
- GWQ FDA UDI
- GMDN Term
- Electroencephalograph FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Category: Electroencephalograph
HydroCel Geodesic Sensor Net - HCGSN 130 by Magstim Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Electroencephalograph.
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- Natus — Natus Neurology Incorporated · Class II
- 128-channel EEG cap (L) — Megin Oy · Class II
- Compumedics Neuvo — COMPUMEDICS LIMITED · Class II
- Zeto ONE Head Unit - Small — ZETO INC · Class II
Cleared under the same submission
K131882 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Magstim Inc.
Sources (2)
- FDA UDI 78e093e7-0040-49c8-9022-550659082db1 33 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 2, 2026