Identity
- Trade Name
- Sapphire II (RX) EUDAMED
- Device Name
- Sapphire II (RX) Coronary Dilatation Catheter EUDAMED
- Model / Reference
- 234-RL-1715J2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934955921674 EUDAMED
- Basic UDI-DI
- B-06934955921674 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 (RX) by OrbusNeich Medical (Shenzhen) Co., Ltd — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Coronary angioplasty balloon catheter, cutting/scoring.
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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-06934955921674 | Class III | Active |
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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 (1)
- EUDAMED b48e8dde-1fd3-497c-86ca-4c449d499acf 61 fields · synced Jun 19, 2026