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Tkl 0311d1
EUDAMEDClass IIb (EU MDR)
Ref TKL 0311D1Model Disposable electrodes defibrillation, cardioversion, cardiac stimulator, ECG
by FIAB S.p.A.
Identity
- Model / Reference
- Disposable electrodes defibrillation, cardioversion, cardiac stimulator, ECG EUDAMEDTKL 0311D1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08058480754052 EUDAMED
- Basic UDI-DI
- 803300326808000007U5 EUDAMED
- EMDN Code
- C020401 EXTERNAL CARDIOVERSION DEFIBRILLATOR ELECTRODE PADS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Tkl 0311d1 by FIAB S.p.A. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 803300326808000007U5 | Class IIb | Active |
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Manufacturer
- Manufacturer
- FIAB S.p.A.
- EUDAMED SRN
- IT-MF-000005988
Sources (1)
- EUDAMED 1bce30cb-6e2d-46d6-990b-217e1d4c1b00 61 fields · synced Sep 18, 2026