Identity
- Trade Name
- SONICAID EUDAMEDDOPPLEX FDA UDI
- Generic Name
- Foetal/maternal prenatal monitor FDA UDI
- Device Name
- 1MHz ULTRASOUND TRANSDUCER (2m) EUDAMEDEVENT MARKER FDA UDI
- Model / Reference
- ACC-OBS-008 EUDAMEDEM1 EUDAMEDFDA UDI
- Description
- EVENT MARKER FDA UDI
Identifiers
- Catalog Number
- EM1 FDA UDI
- Primary DI / UDI-DI
- 05051968018410 EUDAMEDFDA UDI
- Basic UDI-DI
- 5060693520440W7 EUDAMED
- FDA Product Code
- HGM FDA UDI
- EMDN Code
- Z1104018099 ULTRASOUND SCANNERS – HARDWARE ACCESSORIES – OTHER EUDAMED
- GMDN Term
- Foetal/maternal prenatal monitor 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 |
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Manufacturer
- Manufacturer
- ArjoHuntleigh AB
- EUDAMED SRN
- SE-MF-000000696
Sources (2)
- EUDAMED db7353fe-c384-49bd-80bc-3df155629e5c 61 fields · synced Jul 15, 2026
- FDA UDI 626be5ad-a9c0-493a-b630-6ff3aa325f85 36 fields · synced May 29, 2026