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Hepatogram plus
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref RESMPLSAModel Hepatogram plus v3
by Resoundant
Identity
- Trade Name
- Hepatogram plus EUDAMEDFDA UDI
- Generic Name
- MRI system application software FDA UDI
- Device Name
- Hepatogram plus EUDAMED
- Model / Reference
- Hepatogram plus v3 EUDAMEDRESMPLSA EUDAMED3.0DKR FDA UDI
Identifiers
- Catalog Number
- MREPLUSV3 FDA UDI
- Primary DI / UDI-DI
- 00850011790199 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00850011790199 EUDAMED
- 510(k) Number
- K183193 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- EMDN Code
- Z11059082 VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- MRI system application software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Market of Registration
- Italy 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Hepatogram plus by Resoundant — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00850011790199 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Resoundant
- EUDAMED SRN
- US-MF-000037180
- Authorised Representative
- VISAMED GmbH DE-AR-000006285
Sources (2)
- EUDAMED b28e7be8-a7a3-4378-9fa9-a13cf5da3d47 61 fields · synced Jun 19, 2026
- FDA UDI 012dabe6-c0b2-4a50-9158-5289367d2103 34 fields · synced May 30, 2026