Identity
- Trade Name
- Myosist™ EUDAMED
- Device Name
- Myosist™ Intra Aortic Balloon Catheter Kit EUDAMED
- Model / Reference
- MYS0830 EUDAMEDMYS0840 EUDAMEDMYS0835 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18904224917306 EUDAMED18904224917320 EUDAMED18904224917313 EUDAMED
- Basic UDI-DI
- B-18904224917306 EUDAMEDB-18904224917320 EUDAMEDB-18904224917313 EUDAMED
- EMDN Code
- C019001 AORTIC COUNTERPULSATION CATHETERS EUDAMED
Classification
- Device Class
- Class III 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
Myosist™ by Meril Life Sciences Pvt. Ltd. — Class III — 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-18904224917306 | Class III | Active |
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Manufacturer
- Manufacturer
- Meril Life Sciences Pvt. Ltd.
- EUDAMED SRN
- IN-MF-000008308
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (3)
- EUDAMED fef16739-abda-4869-8fde-34013a476d77 61 fields · synced Aug 1, 2026
- EUDAMED eb6936e8-5e14-4321-bb0c-98816db78b2b 61 fields · synced May 18, 2026
- EUDAMED 159ece49-38da-4ca3-b66e-e32f521d9a62 61 fields · synced May 19, 2026