Identity
- Trade Name
- HT Supreme EUDAMED
- Device Name
- HT Supreme Drug Coated Coronary Stent System EUDAMED
- Model / Reference
- BMA-2.2515 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948546208068 EUDAMED
- Basic UDI-DI
- B-06948546208068 EUDAMED
- EMDN Code
- P070402010301 CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Ireland 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
Yes
EUDAMED
HT Supreme by Sino Medical Sciences Technology Inc. — 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-06948546208068 | Class III | Active |
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Manufacturer
- Manufacturer
- Sino Medical Sciences Technology Inc.
- EUDAMED SRN
- CN-MF-000008764
- Authorised Representative
- SINOMED BV NL-AR-000006075
Sources (1)
- EUDAMED 96fc3ab8-4163-446a-8318-e2df7336e549 61 fields · synced Jun 19, 2026