Identity
- Trade Name
- NIC 1.1 hydro EUDAMED
- Device Name
- EasyT EUDAMED
- Model / Reference
- 110-006-134 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640142573098 EUDAMED
- Basic UDI-DI
- 764014257NIC_ETEM EUDAMED
- Direct Marketing DI
- 07640142573098 EUDAMED
- EMDN Code
- C010401020101 PTCA BALLOON DILATION CATHETERS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany 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
NIC 1.1 hydro by SIS Medical AG — Class III — 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 | 764014257NIC_ETEM | Class III | Active |
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Manufacturer
- Manufacturer
- SIS Medical AG
- EUDAMED SRN
- CH-MF-000015821
- Authorised Representative
- EUMEDIQ GmbH DE-AR-000007809
Sources (1)
- EUDAMED bd422205-7a0c-447f-ba2f-8b9599a85f99 61 fields · synced Jun 18, 2026