Sp-L01
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- SP-L01 EUDAMEDInterson FDA UDI
- Generic Name
- Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
- Device Name
- Interson USB Ultrasound Array Probe System EUDAMEDUSB ultrasound probe, small parts FDA UDI
- Model / Reference
- Array Probes (SP-L01, GP-C01, DLX-200-USP) EUDAMED99-7901-00 EUDAMEDSP-L01 FDA UDI
- Description
- USB ultrasound probe, small parts FDA UDI
Identifiers
- Catalog Number
- 99-7901 FDA UDI
- Primary DI / UDI-DI
- 00850921007127 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850921007INT222UT EUDAMED
- FDA Product Code
- IYN FDA UDIIYO FDA UDIITX FDA UDI
- EMDN Code
- Z110402010201 CURVILINEAR TRANSCUTANEOUS TWO–DIMENSIONAL ULTRASOUND PROBES (CONVEX–ARRAY) EUDAMEDZ110402010101 TWO–DIMENSIONAL LINEAR–ARRAY TRANSCUTANEOUS ULTRASOUND PROBES 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
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
Yes
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Extracorporeal ultrasound imaging transducer, hand-held
Sp-L01 by Interson Corporation — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0850921007INT222UT | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Interson Corporation
- EUDAMED SRN
- US-MF-000020801
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (3)
- EUDAMED 0b294fb2-58e6-4364-9b22-1c9704f6732a 61 fields · synced Jun 18, 2026
- FDA UDI 12bb29f2-1e26-49b2-a44a-f996c7dbcd86 35 fields · synced May 30, 2026
- EUDAMED 92b68061-6f05-4b3b-83c0-43fd11a48808 61 fields · synced Jun 18, 2026