Identity
- Trade Name
- OPN NC EUDAMEDFDA UDI
- Generic Name
- Coronary angioplasty balloon catheter, basic FDA UDI
- Device Name
- OPN NC EUDAMEDOPN NC Ø3.5x20 PTCA catheters FDA UDI
- Model / Reference
- 350-020-004 EUDAMEDFDA UDI
- Description
- OPN NC Ø3.5x20 PTCA catheters FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640142570615 EUDAMEDFDA UDI
- Basic UDI-DI
- 764014257OPN_NCKM EUDAMED
- Direct Marketing DI
- 07640142570615 EUDAMED
- 510(k) Number
- K212393 FDA UDI
- FDA Product Code
- LOX FDA UDI
- EMDN Code
- C010401020101 PTCA BALLOON DILATION CATHETERS EUDAMED
- GMDN Term
- Coronary angioplasty balloon catheter, basic FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 870.5100 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Opn Nc by SIS Medical AG — Class III — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 764014257OPN_NCKM | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- SIS Medical AG
- EUDAMED SRN
- CH-MF-000015821
- Authorised Representative
- EUMEDIQ GmbH DE-AR-000007809
Sources (2)
- EUDAMED 0d13d113-3aca-4a3a-af07-fde37e5479ba 61 fields · synced Jul 24, 2026
- FDA UDI 89f8427d-3388-40b5-9203-1a1f981b9d16 35 fields · synced May 30, 2026