Identity
- Trade Name
- GuReater™ EUDAMED
- Device Name
- CoCr Sirolimus-eluting Coronary Stent System EUDAMED
- Model / Reference
- LPRPC4021 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936733715796 EUDAMED
- Basic UDI-DI
- B-06936733715796 EUDAMED
- EMDN Code
- P070402010301 CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
Yes
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
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
Yes
EUDAMED
GuReater™ by Lepu Medical Technology (Beijing) Co., 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-06936733715796 | Class III | Active |
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Manufacturer
- Manufacturer
- Lepu Medical Technology (Beijing) Co., Ltd.
- EUDAMED SRN
- CN-MF-000001408
- Authorised Representative
- Lepu Medical (Europe) Cooperatief U.A. NL-AR-000000551
Sources (1)
- EUDAMED a0cf7c5a-61b7-4648-ac14-7e5914780bba 61 fields · synced Sep 30, 2026