Identity
- Device Name
- Silicone Plugs EUDAMED
- Model / Reference
- 0046-3028 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00813502012088 EUDAMED
- Basic UDI-DI
- B-00813502012088 EUDAMED
- EMDN Code
- C9080 CARDIOCIRCULATORY SYSTEM DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Silicone Plugs by Abiomed, Inc. — Class IIa — 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-00813502012088 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Abiomed Inc.
- EUDAMED SRN
- US-MF-000016855
- Authorised Representative
- Abiomed Europe GmbH DE-AR-000005280
Sources (1)
- EUDAMED a58d0d89-4a29-4aee-9ba5-60a8a2b1b9da 61 fields · synced Aug 4, 2026