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Vital Signs™ Fetal Spiral Electrode for Corometrics™
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 7000AAO
Identity
- Trade Name
- Vital Signs™ Fetal Spiral Electrode for Corometrics™ EUDAMEDVital Signs™ FDA UDI
- Generic Name
- Foetal scalp electrode, spiral FDA UDI
- Device Name
- Vital Signs™ Obstetric Monitoring EUDAMEDVital Signs™ Fetal Spiral Electrode for Corometrics FDA UDI
- Model / Reference
- 7000AAO EUDAMEDFDA UDI
- Description
- Vital Signs™ Fetal Spiral Electrode for Corometrics FDA UDI
Identifiers
- Catalog Number
- 7000AAO FDA UDI
- Primary DI / UDI-DI
- 10889483588406 EUDAMEDFDA UDI
- Basic UDI-DI
- 0889483TF20041gFSEML EUDAMED
- 510(k) Number
- K792669 FDA UDI
- FDA Product Code
- HGP FDA UDI
- EMDN Code
- U100201 FOETAL SCALP ELECTRODES EUDAMED
- GMDN Term
- Foetal scalp electrode, spiral FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 884.2675 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Vital Signs™ Fetal Spiral Electrode for Corometrics™ by AirLife Finland Oy — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 0889483TF20041gFSEML | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- AirLife Finland Oy
- EUDAMED SRN
- FI-MF-000001482
Sources (2)
- EUDAMED ea528a9f-a323-4c88-9430-c886ae66b126 61 fields · synced Oct 5, 2026
- FDA UDI dee7cd36-803d-4b0f-adcb-7ea5eb69fb91 36 fields · synced May 29, 2026