Identity
- Trade Name
- Spectrumedics EUDAMED
- Device Name
- Intravascular Lithotripsy Generator EUDAMED
- Model / Reference
- SPM-3500 EUDAMEDSPM-2400 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974929820015 EUDAMED06974929820008 EUDAMED
- Basic UDI-DI
- 697492982SPM2J EUDAMED
- EMDN Code
- C010499 ANGIOGRAPHY AND HEMODYNAMICS DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
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
No
EUDAMED
Spectrumedics by Spectrumedics Medical Technology (Shanghai) Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697492982SPM2J | Class IIb | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000046123
- Authorised Representative
- BioDomi GmbH DE-AR-000016611
Sources (2)
- EUDAMED 5f5e05cd-b283-4197-8e2d-3d6bbadb1ff1 61 fields · synced Jul 28, 2026
- EUDAMED e8d56e8d-112e-495e-8e30-aa3b673fffdc 61 fields · synced May 18, 2026