Identity
- Trade Name
- NIC Nano hydro EUDAMED
- Device Name
- EasyT EUDAMED
- Model / Reference
- 085-010-134 EUDAMED085-015-134 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640142573036 EUDAMED07640142573043 EUDAMED
- Basic UDI-DI
- 764014257NIC_ETEM EUDAMED
- Direct Marketing DI
- 07640142573036 EUDAMED07640142573043 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
Category: Coronary angioplasty balloon catheter, cutting/scoring
NIC Nano hydro by SIS Medical AG — Class III — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 (2)
- EUDAMED 5f359099-1d9e-4ebe-bc21-2782c9fe1712 61 fields · synced Jul 9, 2026
- EUDAMED dde64039-bd49-4666-92e8-1713aecd9732 61 fields · synced May 18, 2026