Identity
- Trade Name
- Vacutainer EUDAMED
- Device Name
- BD Vacutainer® Eclipse™ Signal™ Blood Collection Needle EUDAMED
- Model / Reference
- 368835 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 30382903688358 EUDAMED
- Basic UDI-DI
- 038290QRCKHJAHCL EUDAMED
- Unit of Use DI
- 00382903688357 EUDAMED
- EMDN Code
- A01010501 NEEDLES FOR COLLECTION UNDER VACUUM, WITH SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium 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
Vacutainer by Becton, Dickinson and Company — 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 | 038290QRCKHJAHCL | Class IIa | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
- EUDAMED SRN
- US-MF-000019182
- Authorised Representative
- Becton Dickinson Ireland Limited IE-AR-000007610
Sources (1)
- EUDAMED 680b7ccc-30e5-40e5-911e-05f8ac595dae 61 fields · synced Oct 9, 2026