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F9007
EUDAMEDFDA UDIClass I (EU MDR)
Ref F9007Model Reusable electrodes for ECG
by FIAB S.p.A.
Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Electrocardiographic electrode, reusable FDA UDI
- Device Name
- Rubber balls for FIAB suction chest electrodes, Ø 33mm dimensions. F9007 model is used as a replacement of old rubber balls. They are made of blue PVC. LATEX free. FIAB compatible ref models F9003 – F9009 – F9016 FDA UDI
- Model / Reference
- Reusable electrodes for ECG EUDAMEDF9007 EUDAMEDFDA UDI
- Description
- Rubber balls for FIAB suction chest electrodes, Ø 33mm dimensions. F9007 model is used as a replacement of old rubber balls. They are made of blue PVC. LATEX free. FIAB compatible ref models F9003 – F9009 – F9016 FDA UDI
Identifiers
- Catalog Number
- F9007 FDA UDI
- Primary DI / UDI-DI
- 08033695721723 EUDAMEDFDA UDI
- Basic UDI-DI
- 803300326008000001MZ EUDAMED
- FDA Product Code
- DRX FDA UDI
- EMDN Code
- C020501 ECG ELECTRODES EUDAMED
- GMDN Term
- Electrocardiographic electrode, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2360 FDA UDI
- Market of Registration
- Italy 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electrocardiographic electrode, single-use
F9007 by FIAB S.p.A. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Electrocardiographic electrode, single-use.
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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 | 803300326008000001MZ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- FIAB S.p.A.
- EUDAMED SRN
- IT-MF-000005988
Sources (2)
- EUDAMED 83aa0147-0372-46a3-b86a-a7dec5b19490 61 fields · synced Jul 13, 2026
- FDA UDI 4b45b0ad-7e5a-46e0-baff-5136fbc588d4 36 fields · synced May 30, 2026