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BD SmartSite
EUDAMEDClass I (EU MDR)
Ref MV0413-0006Model BD SmartSiteRef MV0520-0006Ref MV0428-0006Ref MV042005-0006Ref MV040025-0006Ref MV0400-0006Ref MV040010-0006Ref MV042025-0006
Identity
- Trade Name
- BD SmartSite EUDAMED
- Device Name
- BD 13mm SmartSite Vented Vial Access Device EUDAMEDBD 20mm SmartSite VialShield Closed Vial Access Device EUDAMEDBD 28mm SmartSite Vented Vial Access Device EUDAMEDBD 20mm SmartSite Vented Vial Access Device EUDAMEDBD Universal SmartSite Vented Vial Access Device Multipack (25 pcs) EUDAMEDBD Universal SmartSite Vented Vial Access Device EUDAMEDBD 20mm SmartSite Vented Vial Access Device Multipack (25 pcs) EUDAMED
- Model / Reference
- BD SmartSite EUDAMEDMV0413-0006 EUDAMEDMV0520-0006 EUDAMEDMV0428-0006 EUDAMEDMV042005-0006 EUDAMEDMV040025-0006 EUDAMEDMV0400-0006 EUDAMEDMV040010-0006 EUDAMEDMV042025-0006 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10885403228476 EUDAMED10885403229046 EUDAMED10885403228490 EUDAMED27613203028572 EUDAMED10885403427916 EUDAMED07613203028806 EUDAMED27613203028510 EUDAMED10885403428227 EUDAMED
- Basic UDI-DI
- B-10885403228476 EUDAMEDB-10885403229046 EUDAMEDB-10885403228490 EUDAMEDB-27613203028572 EUDAMEDB-10885403427916 EUDAMEDB-07613203028806 EUDAMEDB-27613203028510 EUDAMEDB-10885403428227 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-10885403228476 | 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 (8)
- EUDAMED ad3f2718-02af-4e26-9fb2-6679e9b22543 61 fields · synced Aug 2, 2026
- EUDAMED 2ba7e349-8f2d-4744-9a2d-bdec3bea3a27 61 fields · synced May 17, 2026
- EUDAMED 3694faec-1e23-4f01-969d-a1275d79f9a8 61 fields · synced May 17, 2026
- EUDAMED 628c4766-1b3c-4b8a-b0c9-b109b9e7e54d 61 fields · synced May 18, 2026
- EUDAMED 392af453-9b9c-4973-bef0-067efed45495 61 fields · synced May 18, 2026
- EUDAMED d38c573e-eaa9-48b2-b391-60a551551f5e 61 fields · synced May 18, 2026
- EUDAMED 88a57741-37b7-4e6e-b780-eae00da87cf9 61 fields · synced May 18, 2026
- EUDAMED a5ca2a8f-c418-489f-80fc-3c32cd0798d4 61 fields · synced May 19, 2026