Identity
- Trade Name
- Solar GI HRIM Solid State, Trolley system FDA UDI
- Generic Name
- Gastroduodenal motility analysis system FDA UDI
- Model / Reference
- G3-10 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08717775955108 FDA UDI
- 510(k) Number
- K052338 FDA UDI
- FDA Product Code
- FFX FDA UDI
- GMDN Term
- Gastroduodenal motility analysis system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1725 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
No
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: Gastroduodenal motility analysis system
Solar GI HRIM Solid State, Trolley system by Medical Measurement Systems B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Gastroduodenal motility analysis system.
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- CIM AUX HRIM — Medical Measurement Systems B.V. · Class II
- MPP Plus — Medical Measurement Systems B.V. · Class II
- Solar GI HRM Solid State, Trolley system — Medical Measurement Systems B.V. · Class II
- CIM AUX + C/HRM — Medical Measurement Systems B.V. · Class II
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Medical Measurement Systems B.V.
Sources (1)
- FDA UDI 0fdb37ea-790b-4bb0-b043-35e92b86fff1 33 fields · synced May 30, 2026