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Resoundant Flex Passive Driver, Small
EUDAMEDFDA UDIClass I (EU MDR)
Ref REFPDS19
by Resoundant
Identity
- Trade Name
- Resoundant Flex Passive Driver, Small EUDAMEDFlex Passive Driver Kit- Small FDA UDI
- Generic Name
- Magnetic resonance elastography acoustic driver FDA UDI
- Device Name
- Flex Passive Driver, Small EUDAMED
- Model / Reference
- REFPDS19 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850011790052 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850011790REFPDS19JC 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 Unsafe FDA UDI
Resoundant Flex Passive Driver, Small 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 | 0850011790REFPDS19JC | 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 d71d2ee1-c39c-47e5-b040-b64b4b376a51 61 fields · synced Jul 16, 2026
- FDA UDI 44714b7a-a6d4-4c0e-8990-18eb1bc572a9 33 fields · synced May 25, 2026