← Back to catalogue
Saf-T-Intima
EUDAMEDClass IIa (EU MDR)
Ref 383318Ref 383319Ref 383329Ref 383348Ref 383328
Identity
- Trade Name
- Saf-T-Intima EUDAMED
- Device Name
- BD Saf-T-Intima™ Safety System EUDAMED
- Model / Reference
- 383318 EUDAMED383319 EUDAMED383329 EUDAMED383348 EUDAMED383328 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00382903833184 EUDAMED00382903833191 EUDAMED00382903833290 EUDAMED00382903833481 EUDAMED00382903833283 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Becton Dickinson Infusion Therapy Systems Inc.
- EUDAMED SRN
- US-MF-000017719
- Authorised Representative
- Becton Dickinson Ireland Limited IE-AR-000007610
Sources (5)
- EUDAMED 401e1234-0c74-4ecb-af22-234f271e044c 61 fields · synced Jul 13, 2026
- EUDAMED d1cb3d93-9bd6-4b1b-a851-a271c770dbc3 61 fields · synced May 17, 2026
- EUDAMED 377422e6-314f-43a4-853c-ac3ae5009433 61 fields · synced May 17, 2026
- EUDAMED 8e40bdd1-1da8-48a3-a09b-c9e00d23c826 61 fields · synced May 18, 2026
- EUDAMED 78e1c957-70eb-4e5b-9c02-0efeba9bf9cc 61 fields · synced Jun 20, 2026