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Promesa™ BMS
EUDAMEDClass IIb (EU MDR)
Ref PRB0500060BModel Usable length 120 cm
Identity
- Trade Name
- Promesa™ BMS EUDAMED
- Device Name
- Promesa™ BMS Self-Expanding Nitinol Peripheral Stent System EUDAMED
- Model / Reference
- Usable length 120 cm EUDAMEDPRB0500060B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18904224919713 EUDAMED
- Basic UDI-DI
- B-18904224919713 EUDAMED
- EMDN Code
- P070402020102 NON-STAINLESS STEEL PERIPHERAL VASCULAR BARE METAL STENTS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
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
Promesa™ BMS by Meril Life Sciences Pvt. Ltd. — Class IIb — 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-18904224919713 | Class IIb | 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 055879a2-b27f-4286-9276-8567560d8172 61 fields · synced Jun 18, 2026