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Pr53
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref PR53Model ENDOCAVITORY ULTRASOUND PROBES
by Sonoscanner
Identity
- Trade Name
- PR53 EUDAMEDU-Lite FDA UDI
- Generic Name
- Rectal/vaginal ultrasound imaging transducer FDA UDI
- Device Name
- Endocavitary Probe 4-9 Mhz FDA UDI
- Model / Reference
- ENDOCAVITORY ULTRASOUND PROBES EUDAMEDPR53 EUDAMEDFDA UDI
- Description
- Endocavitary Probe 4-9 Mhz FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03701104600086 EUDAMEDFDA UDI
- Basic UDI-DI
- 37011046ENDUSPROBESLM EUDAMED
- Direct Marketing DI
- 03701104600086 EUDAMED
- 510(k) Number
- K171164 FDA UDI
- FDA Product Code
- ITX FDA UDI
- EMDN Code
- Z1104020201 ENDOCAVITARY ULTRASOUND PROBES, TWO–DIMENSIONAL EUDAMED
- GMDN Term
- Rectal/vaginal ultrasound imaging transducer FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1570 FDA UDI
- Market of Registration
- France 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Pr53 by Sonoscanner — Class IIa — 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 | 37011046ENDUSPROBESLM | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Sonoscanner
- EUDAMED SRN
- FR-MF-000002220
Sources (2)
- EUDAMED b16a0230-58ac-469a-8519-6e61ae372fb6 61 fields · synced Jun 18, 2026
- FDA UDI 635785a1-108c-4363-9086-a46a47b71bb3 34 fields · synced May 30, 2026