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Resoundant Passive Driver, Rigid
EUDAMEDFDA UDIClass I (EU MDR)
Ref REPD2000
by Resoundant
Identity
- Trade Name
- Resoundant Passive Driver, Rigid EUDAMEDPassive Driver FDA UDI
- Generic Name
- Magnetic resonance elastography acoustic driver FDA UDI
- Device Name
- Passive Driver, Rigid EUDAMED
- Model / Reference
- REPD2000 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850011790106 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850011790REPD20008L EUDAMED
- 510(k) Number
- K201389 FDA UDI
- FDA Product Code
- LNH FDA UDI
- EMDN Code
- Z11059080 VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Magnetic resonance elastography acoustic driver FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1000 FDA UDI
- Market of Registration
- Germany 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Resoundant Passive Driver, Rigid by Resoundant — 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 | 0850011790REPD20008L | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Resoundant
- EUDAMED SRN
- US-MF-000037180
- Authorised Representative
- VISAMED GmbH DE-AR-000006285
Sources (2)
- EUDAMED fb214350-6fa0-4ab9-b279-33fa567b9d41 61 fields · synced Jun 18, 2026
- FDA UDI e2bccce7-1771-44f6-9349-f77692607512 33 fields · synced May 30, 2026