Identity
- Trade Name
- Sapphire II PRO EUDAMED
- Device Name
- Sapphire II PRO EUDAMED
- Model / Reference
- Ø 1.25 x 10 mm EUDAMED212-103-5U EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08717853296604 EUDAMED
- Basic UDI-DI
- B-08717853296604 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
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
Category: Coronary angioplasty balloon catheter, cutting/scoring
Sapphire II PRO by OrbusNeich Medical, B.V. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Coronary angioplasty balloon catheter, cutting/scoring.
- Sterile PTA Balloon Catheter — Zhejiang Barty Medical Technology Co., Ltd. · Class IIa
- Sterile PTA Balloon Catheter — Zhejiang Barty Medical Technology Co., Ltd. · Class IIa
- Pipit SC — Sahajanand Medical Technologies Limited · Class III
- Kulani™ NC — Meril Life Sciences Pvt. Ltd. · Class III
- Invader PTCA — Alvimedica Tibbi Urunler San. ve Dis Tic. A.S. · Class III
- Wolverine Coronary Cutting Balloon — Boston Scientific · Class III
- Pipit SC — Sahajanand Medical Technologies Limited · Class III
- POT — BrosMed Medical Co., Ltd. · Class III
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08717853296604 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- OrbusNeich Medical, B.V.
- EUDAMED SRN
- NL-MF-000010907
Sources (1)
- EUDAMED 2fdff755-8e1f-47b5-b9a6-aa4984f4c0f5 61 fields · synced Jun 9, 2026