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Dafodil™ Pericardial Bioprosthesis Valve
EUDAMEDClass III (EU MDR)
Ref PBASS1927
Identity
- Device Name
- Dafodil™ Pericardial Bioprosthesis Valve EUDAMED
- Model / Reference
- PBASS1927 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18904224958163 EUDAMED
- Basic UDI-DI
- 89042249PBE8 EUDAMED
- Direct Marketing DI
- 18904224958163 EUDAMED
- EMDN Code
- P07038001 HEART VALVE IMPLANT SIZERS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Heart valve annulus sizer, reusable
Dafodil™ Pericardial Bioprosthesis Valve by Meril Life Sciences Pvt. Ltd. — Class III — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 89042249PBE8 | 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 (1)
- EUDAMED fcddb9b1-0752-4552-a5a7-a6ad0a357320 61 fields · synced Jun 18, 2026