Identity
- Trade Name
- Multi-Point 1.5 Thermal Sensor™ EUDAMED
- Device Name
- Cryoablation Needles - Classic EUDAMED
- Model / Reference
- H7493963340100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00191506017002 EUDAMED
- Basic UDI-DI
- 01915060000000000000402MQ EUDAMED
- EMDN Code
- Z120102 CRYOSURGERY EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
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
Multi-Point 1.5 Thermal Sensor™ by Boston Scientific Corporation — Class IIa — 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 | 01915060000000000000402MQ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Boston Scientific Corporation
- EUDAMED SRN
- US-MF-000004702
- Authorised Representative
- Boston Scientific Limited IE-AR-000003840
Sources (1)
- EUDAMED f4f42539-a760-460a-90ff-aa06e5ce733b 61 fields · synced Jul 10, 2026