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DynamX Sirolimus Eluting Coronary Bioadaptor System
EUDAMEDClass III (EU MDR)
Ref VIR2743Model VIR2014Ref VIR2714Ref VIR2523Ref VIR3538Ref VIR4028Ref VIR3018Ref VIR3546Ref VIR2218Ref VIR2046Ref VIR2243Ref VIR3023Ref VIR2532Ref VIR3528Ref VIR2732Ref VIR2518Ref VIR2232Ref VIR3548Ref VIR2032Ref VIR2228Ref VIR4023Ref VIR2528Ref VIR2746Ref VIR2538Ref VIR3032Ref VIR2223Ref VIR3523Ref VIR3028Ref VIR4018Ref VIR2718Ref VIR2546Ref VIR3014Ref VIR2043Ref VIR2748Ref VIR2018Ref VIR2738
Identity
- Trade Name
- DynamX Sirolimus Eluting Coronary Bioadaptor System EUDAMED
- Device Name
- DynamX Sirolimus Eluting Coronary Bioadaptor System EUDAMED
- Model / Reference
- VIR2014 EUDAMEDVIR2743 EUDAMEDVIR2714 EUDAMEDVIR2523 EUDAMEDVIR3538 EUDAMEDVIR4028 EUDAMEDVIR3018 EUDAMEDVIR3546 EUDAMEDVIR2218 EUDAMEDVIR2046 EUDAMEDVIR2243 EUDAMEDVIR3023 EUDAMEDVIR2532 EUDAMEDVIR3528 EUDAMEDVIR2732 EUDAMEDVIR2518 EUDAMEDVIR2232 EUDAMEDVIR3548 EUDAMEDVIR2032 EUDAMEDVIR2228 EUDAMEDVIR4023 EUDAMEDVIR2528 EUDAMEDVIR2746 EUDAMEDVIR2538 EUDAMEDVIR3032 EUDAMEDVIR2223 EUDAMEDVIR3523 EUDAMEDVIR3028 EUDAMEDVIR4018 EUDAMEDVIR2718 EUDAMEDVIR2546 EUDAMEDVIR3014 EUDAMEDVIR2043 EUDAMEDVIR2748 EUDAMEDVIR2018 EUDAMEDVIR2738 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00817508015203 EUDAMED00817508012912 EUDAMED00817508012875 EUDAMED00817508013087 EUDAMED00817508013650 EUDAMED00817508012981 EUDAMED00817508015272 EUDAMED00817508012806 EUDAMED00817508015128 EUDAMED00817508015142 EUDAMED00817508012998 EUDAMED00817508012899 EUDAMED00817508013063 EUDAMED00817508012950 EUDAMED00817508012868 EUDAMED00817508012837 EUDAMED00817508015289 EUDAMED00817508015098 EUDAMED00817508012820 EUDAMED00817508013643 EUDAMED00817508012882 EUDAMED00817508015210 EUDAMED00817508012905 EUDAMED00817508013018 EUDAMED00817508012813 EUDAMED00817508013056 EUDAMED00817508013001 EUDAMED00817508013636 EUDAMED00817508012929 EUDAMED00817508015050 EUDAMED00817508015180 EUDAMED00817508012974 EUDAMED00817508015111 EUDAMED00817508015227 EUDAMED00817508015067 EUDAMED00817508012967 EUDAMED
- Basic UDI-DI
- 081750801DynamXVIR4F EUDAMED
- EMDN Code
- P07040199 VASCULAR ENDOPROSTHESES - OTHER EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Sweden EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMEDEUDAMED
CMR Substance
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
Yes
EUDAMED
DynamX Sirolimus Eluting Coronary Bioadaptor System by Elixir Medical Corporation — Class III — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081750801DynamXVIR4F | Class III | Active |
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Manufacturer
- Manufacturer
- Elixir Medical Corporation
- EUDAMED SRN
- US-MF-000013041
- Authorised Representative
- Acorn Regulatory Consultancy Services Ltd IE-AR-000000592
Sources (36)
- EUDAMED 799e2c85-2a12-4b24-888e-f4be4746572c 61 fields · synced Sep 18, 2026
- EUDAMED 8ac61e29-2b5e-4f2f-a73e-4b55cdfc068c 61 fields · synced May 11, 2026
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- EUDAMED eb0bd44d-c398-488b-93e8-db4410aa643a 61 fields · synced May 16, 2026
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- EUDAMED a00c6fad-c4ed-42f9-9e24-59104b787e2c 61 fields · synced May 17, 2026
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- EUDAMED fbab560c-1caa-4fca-b87a-6cc516479dbf 61 fields · synced May 17, 2026
- EUDAMED 9dcbc465-f2ba-4f9b-8714-727311bd5085 61 fields · synced May 17, 2026
- EUDAMED 55644a5e-24df-41fa-8894-43b44cc75543 61 fields · synced May 17, 2026
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- EUDAMED 48f52bc3-3c72-42f2-aaeb-7a9e6a43c9f6 61 fields · synced May 17, 2026
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- EUDAMED d43fb5c2-ac78-4324-b97f-239b29db9cb8 61 fields · synced May 17, 2026
- EUDAMED 88939b78-6c04-438f-8167-8053a36e443c 61 fields · synced May 17, 2026
- EUDAMED 5c06cbc6-3ef4-45c4-9583-375e009a7e0d 61 fields · synced May 18, 2026
- EUDAMED b913f5ec-de53-4c7b-a7a2-a1e691f0017c 61 fields · synced May 18, 2026
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