Identity
- Trade Name
- 5P1e Transducer FDA UDI
- Generic Name
- Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
- Device Name
- "Abdominal adult and pediatric, Adult and pediatric Cephalic (transcranial) , Cardiac Adult and pediatric*, CW Doppler *not for use directly on the heart" FDA UDI
- Model / Reference
- 9087 FDA UDI
- Description
- "Abdominal adult and pediatric, Adult and pediatric Cephalic (transcranial) , Cardiac Adult and pediatric*, CW Doppler *not for use directly on the heart" FDA UDI
Identifiers
- Catalog Number
- 9087 FDA UDI
- Primary DI / UDI-DI
- 05704916000370 FDA UDI
- FDA Product Code
- ITX FDA UDI
- GMDN Term
- Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Extracorporeal ultrasound imaging transducer, hand-held
5P1e Transducer by Bk Medical ApS — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Bk Medical ApS
Sources (2)
- FDA UDI 1c8402cd-9045-4aad-b75d-b19895aba4c2 36 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 18, 2026