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Axillary Insertion Graft Lock
EUDAMEDClass I (EU MDR)
Ref 0052-3008-EU
by Abiomed Inc.
Identity
- Device Name
- Axillary Insertion Graft Lock EUDAMED
- Model / Reference
- 0052-3008-EU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00813502012231 EUDAMED
- Basic UDI-DI
- B-00813502012231 EUDAMED
- EMDN Code
- C9080 CARDIOCIRCULATORY SYSTEM DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class I 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
Axillary Insertion Graft Lock by Abiomed, Inc. — 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-00813502012231 | Class I | 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 d10817d7-3737-41f8-b60b-6ae1675f9310 61 fields · synced Jun 19, 2026