Identity
- Trade Name
- Saf-T-Intima EUDAMED
- Device Name
- BD Saf-T-Intima™ Safety System EUDAMED
- Model / Reference
- 383338 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00382903833382 EUDAMED
- Basic UDI-DI
- 038290ESLWZLJRKH EUDAMED
- EMDN Code
- C01010103 PERIPHERAL I.V. CATHETERS, WITH INTEGRATED EXTENSIONS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Saf-T-Intima by Becton Dickinson Infusion Therapy Systems Inc. — Class IIa — 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 | 038290ESLWZLJRKH | Class IIa | Active |
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Manufacturer
- Manufacturer
- Becton Dickinson Infusion Therapy Systems Inc.
- EUDAMED SRN
- US-MF-000017719
- Authorised Representative
- Becton Dickinson Ireland Limited IE-AR-000007610
Sources (1)
- EUDAMED c8804379-1c37-44f3-b942-2f9b9f9bbec9 61 fields · synced Jun 9, 2026