Identity
- Trade Name
- Coronary Analysis System EUDAMED
- Device Name
- Coronary Analysis System EUDAMED
- Model / Reference
- ASC15 EUDAMEDClass Ⅱa EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971381280210 EUDAMED
- Basic UDI-DI
- B-06971381280210 EUDAMED
- EMDN Code
- C0104010199 CARDIAC ANGIOGRAPHY DIAGNOSTIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Coronary Analysis System by Suzhou RainMed Medical Technology Co., Ltd. — Class IIa — 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-06971381280210 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Suzhou RainMed Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000018894
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (1)
- EUDAMED 41786403-cc21-4b59-bc31-003fca6b985d 61 fields · synced Jul 22, 2026