Identity
- Trade Name
- BD SmartSite EUDAMED
- Device Name
- BD Universal SmartSite VialShield Closed Vial Access Device EUDAMED
- Model / Reference
- BD SmartSite EUDAMEDMV0550-0006 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07613203030793 EUDAMED
- Basic UDI-DI
- B-07613203030793 EUDAMED
- EMDN Code
- A070199 ADAPTERS AND CONNECTORS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
BD SmartSite by Yukon Medical, LLC — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-07613203030793 | Class I | Active |
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Manufacturer
- Manufacturer
- Yukon Medical, LLC
- EUDAMED SRN
- US-MF-000027131
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 901e6960-5426-47b6-81d5-370cd892e35d 61 fields · synced Jun 18, 2026