Identity
- Trade Name
- SONICAID EUDAMEDFDA UDI
- Generic Name
- Foetal/maternal prenatal monitor FDA UDI
- Device Name
- ANTEPARTUM/PRINTER EUDAMEDTEAM3 ANTEPARTUM/ECTG USA FDA UDI
- Model / Reference
- TEAM3A EUDAMEDTEAM3A E EUDAMEDTEAM3A-E/USA FDA UDI
- Description
- TEAM3 ANTEPARTUM/ECTG USA FDA UDI
Identifiers
- Catalog Number
- TEAM3A-E-USA FDA UDI
- Primary DI / UDI-DI
- 05051968032508 EUDAMEDFDA UDI
- Basic UDI-DI
- 5060693520389WY EUDAMED
- 510(k) Number
- K200975 FDA UDI
- FDA Product Code
- HGM FDA UDI
- EMDN Code
- Z12080101 FOETAL MONITORS EUDAMED
- GMDN Term
- Foetal/maternal prenatal monitor FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 884.2740 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- Not 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
Yes
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 IIb — 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 | 5060693520389WY | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | 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 06b18d04-96d7-4fed-ae61-ccf8cf868dbb 61 fields · synced Jun 17, 2026
- FDA UDI 758c316c-7cab-4e2c-85f7-8cfcddd8661d 38 fields · synced May 30, 2026