Identity
- Trade Name
- Sapphire 3 EUDAMEDSapphire NC Plus FDA UDI
- Generic Name
- Coronary angioplasty balloon catheter, basic FDA UDI
- Device Name
- Sapphire 3 Coronary Dilatation Catheter EUDAMEDPercutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter FDA UDI
- Model / Reference
- 215-203-6J EUDAMED215-103-6J EUDAMED250-123-2U FDA UDI
- Description
- Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06934955954146 EUDAMED06934955954115 EUDAMED06934955934636 FDA UDI
- Basic UDI-DI
- B-06934955954146 EUDAMEDB-06934955954115 EUDAMED
- 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Dimensions & Sizes
- Size
- Outer Diameter — 5.0 Millimeter FDA UDILength — 12 Millimeter FDA UDI
Sapphire 3 by OrbusNeich Medical (Shenzhen) Co., Ltd — Class III — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06934955954146 | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- OrbusNeich Medical (Shenzhen) Co., Ltd
- EUDAMED SRN
- CN-MF-000011345
- Authorised Representative
- Quality First International OÜ EE-AR-000004308
Sources (3)
- EUDAMED 3a303ebc-96bd-45b0-96b1-b69c2ad0ba48 61 fields · synced Jul 30, 2026
- FDA UDI c5a20fd4-482f-41fb-a135-a89bed93b1f8 36 fields · synced May 24, 2026
- EUDAMED f1b96d0b-292b-472d-8798-b916f0a4ff52 61 fields · synced Jul 30, 2026