Identity
- Trade Name
- SONICAID EUDAMEDFDA UDI
- Generic Name
- Cardiotocography telemetric monitoring system FDA UDI
- Device Name
- 1MHz ULTRASOUND TRANSDUCER (2m) EUDAMEDFREEDOM TOCO TDR FDA UDI
- Model / Reference
- ACC-OBS-008 EUDAMEDACC-OBS-053 EUDAMEDSF1-TOCO FDA UDI
- Description
- FREEDOM TOCO TDR FDA UDI
Identifiers
- Catalog Number
- SF1-TOCO FDA UDI
- Primary DI / UDI-DI
- 05051968032416 EUDAMEDFDA UDI
- Basic UDI-DI
- 5060693520440W7 EUDAMED
- 510(k) Number
- K132650 FDA UDI
- FDA Product Code
- HGM FDA UDI
- EMDN Code
- Z1104018099 ULTRASOUND SCANNERS – HARDWARE ACCESSORIES – OTHER EUDAMED
- GMDN Term
- Cardiotocography telemetric monitoring system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 884.2740 FDA UDI
- Market of Registration
- Ireland 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
Sonicaid by Arjohuntleigh AB — 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 | 5060693520440W7 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- ArjoHuntleigh AB
- EUDAMED SRN
- SE-MF-000000696
Sources (2)
- EUDAMED 1748c7fb-d01e-4dbb-b809-2028f6e7ac44 61 fields · synced Jul 27, 2026
- FDA UDI 3efbefde-bc0d-4770-b0e1-4024209a7b45 37 fields · synced May 29, 2026