Identity
- Trade Name
- BD SmartSite EUDAMED
- Device Name
- BD 28mm SmartSite VialShield Closed Vial Access Device EUDAMED
- Model / Reference
- BD SmartSite EUDAMEDMV0528-0006 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10885403229053 EUDAMED
- Basic UDI-DI
- B-10885403229053 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-10885403229053 | 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 2f5de628-3a01-44f4-9a9a-fbaaa4c51deb 61 fields · synced Jun 17, 2026