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F9011p
EUDAMEDFDA UDIClass I (EU MDR)
Ref F9011PModel Fastening elastic rubber belts
by FIAB S.p.A.
Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Electrode/transducer strap, reusable FDA UDI
- Device Name
- F9011P is a rubber belts used to fix limb electrodes for ECG.The rubber belt is made of biocompatible natural rubber, without additives and not irritating. Width 17 +/- 1 mm Length 26 +/-0.5 cm FDA UDI
- Model / Reference
- Fastening elastic rubber belts EUDAMEDF9011P EUDAMEDFDA UDI
- Description
- F9011P is a rubber belts used to fix limb electrodes for ECG.The rubber belt is made of biocompatible natural rubber, without additives and not irritating. Width 17 +/- 1 mm Length 26 +/-0.5 cm FDA UDI
Identifiers
- Catalog Number
- F9011P FDA UDI
- Primary DI / UDI-DI
- 08033003267417 EUDAMEDFDA UDI
- Basic UDI-DI
- 803300326708000001T2 EUDAMED
- FDA Product Code
- DRX FDA UDI
- EMDN Code
- C0280 ARRYTHMOLOGY DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- Electrode/transducer strap, 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
Yes
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
F9011p by FIAB S.p.A. — 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 | 803300326708000001T2 | 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 d1b884e2-0a1e-446e-95ae-ebbf1e3ba97c 61 fields · synced Jul 10, 2026
- FDA UDI 94b3e0be-d6b1-480a-80c3-73f809e7084c 36 fields · synced May 30, 2026