Identity
- Trade Name
- Transducer C10-3v, Variant 3 EUDAMEDTransducer C10-3v FDA UDI
- Generic Name
- Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
- Device Name
- Invasive (Rectal/Vaginal) Transducers EUDAMED
- Model / Reference
- 989605381663 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884838067509 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM430SP EUDAMED
- FDA Product Code
- IYN FDA UDIIYO FDA UDIITX FDA UDI
- EMDN Code
- Z1104020201 ENDOCAVITARY ULTRASOUND PROBES, TWO–DIMENSIONAL EUDAMED
- GMDN Term
- Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1550 FDA UDI892.1560 FDA UDI892.1570 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
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
Transducer C10-3v, Variant 3 by Philips Ultrasound LLC — 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 | 0884838BM430SP | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Philips Ultrasound LLC
- EUDAMED SRN
- US-MF-000002237
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (2)
- EUDAMED 6e8ad790-b551-4877-9441-51259c3ecad8 61 fields · synced Jun 19, 2026
- FDA UDI e8b6021e-ab66-4286-a2e5-93f00ef90936 32 fields · synced May 30, 2026