← Back to catalogue
Sapphire NC 24
EUDAMEDClass III (EU MDR)
Ref 217-264-5Model Ø1.75 x 26 mmRef 240-183-2Model Ø 4.0 x 18 mmRef 230-264-5Model Ø3.0 x 26 mmRef 225-084-5Model Ø2.5 x 08 mmRef 250-154-5Model Ø 5.0 x 15 mmRef 222-123-2Model Ø 2.25 x 12 mmRef 227-123-2Model Ø 2.75 x 12 mmRef 245-224-5Model Ø 4.5 x 22 mmRef 235-183-2Model Ø 3.5 x 18 mmRef 222-224-5Model Ø2.25 x 22 mmRef 217-124-5Model Ø1.75 x 12 mmRef 227-153-2Model Ø 2.75 x 15 mmRef 232-184-5Model Ø3.25 x 18 mmRef 220-124-5Model Ø2.0 x 12 mmRef 227-124-5Model Ø2.75 x 12 mmRef 220-123-2Model Ø 2.0 x 12 mmRef 225-103-2Model Ø 2.5 x 10 mmRef 235-123-2Model Ø 3.5 x 12 mmRef 230-083-2Model Ø 3.0 x 8 mmRef 245-104-5Model Ø 4.5 x 10 mmRef 250-124-5Model Ø 5.0 x 12 mmRef 227-104-5Model Ø2.75 x 10 mmRef 237-124-5Model Ø 3.75 x 12 mmRef 222-153-2Model Ø 2.25 x 15 mmRef 220-153-2Model Ø 2.0 x 15 mmRef 227-184-5Model Ø2.75 x 18 mmRef 245-123-2Model Ø 4.5 mm x 12 mmRef 232-123-2Model Ø 3.25 x 12 mmRef 250-083-2Model Ø 5.0 mm x 8 mmRef 250-084-5Model Ø 5.0 x 08 mmRef 217-184-5Model Ø1.75 x 18 mmRef 235-264-5Model Ø3.5 x 26 mmRef 237-184-5Model Ø 3.75 x 18 mmRef 228-154-5Model Ø2.875 x 15 mmRef 232-083-2Model Ø 3.25 x 8 mmRef 240-123-2Model Ø 4.0 x 12 mmRef 227-224-5Model Ø2.75 x 22 mmRef 220-184-5Model Ø2.0 x 18 mmRef 228-184-5Model Ø2.875 x 18 mmRef 215-264-5Model Ø1.5 x 26 mmRef 237-224-5Model Ø 3.75 x 22 mmRef 237-104-5Model Ø3.75 x 10 mmRef 222-084-5Model Ø2.25 x 08 mmRef 245-183-2Model Ø 4.5 mm x 18 mmRef 230-124-5Model Ø3.0 x 12 mmRef 245-083-2Model Ø 4.5 mm x 8 mmRef 250-123-2Model Ø 5.0 mm x 12 mmRef 227-083-2Model Ø 2.75 x 8 mmRef 240-084-5Model Ø 4.0 x 08 mmRef 237-153-2Model Ø 3.75 x 15 mmRef 222-184-5Model Ø2.25 x 18 mm
Identity
- Trade Name
- Sapphire NC 24 EUDAMEDSapphire NC EUDAMED
- Device Name
- Sapphire NC 24 EUDAMEDSapphire NC EUDAMED
- Model / Reference
- Ø1.75 x 26 mm EUDAMED217-264-5 EUDAMEDØ 4.0 x 18 mm EUDAMED240-183-2 EUDAMEDØ3.0 x 26 mm EUDAMED230-264-5 EUDAMEDØ2.5 x 08 mm EUDAMED225-084-5 EUDAMEDØ 5.0 x 15 mm EUDAMED250-154-5 EUDAMEDØ 2.25 x 12 mm EUDAMED222-123-2 EUDAMEDØ 2.75 x 12 mm EUDAMED227-123-2 EUDAMEDØ 4.5 x 22 mm EUDAMED245-224-5 EUDAMEDØ 3.5 x 18 mm EUDAMED235-183-2 EUDAMEDØ2.25 x 22 mm EUDAMED222-224-5 EUDAMEDØ1.75 x 12 mm EUDAMED217-124-5 EUDAMEDØ 2.75 x 15 mm EUDAMED227-153-2 EUDAMEDØ3.25 x 18 mm EUDAMED232-184-5 EUDAMEDØ2.0 x 12 mm EUDAMED220-124-5 EUDAMEDØ2.75 x 12 mm EUDAMED227-124-5 EUDAMEDØ 2.0 x 12 mm EUDAMED220-123-2 EUDAMEDØ 2.5 x 10 mm EUDAMED225-103-2 EUDAMEDØ 3.5 x 12 mm EUDAMED235-123-2 EUDAMEDØ 3.0 x 8 mm EUDAMED230-083-2 EUDAMEDØ 4.5 x 10 mm EUDAMED245-104-5 EUDAMEDØ 5.0 x 12 mm EUDAMED250-124-5 EUDAMEDØ2.75 x 10 mm EUDAMED227-104-5 EUDAMEDØ 3.75 x 12 mm EUDAMED237-124-5 EUDAMEDØ 2.25 x 15 mm EUDAMED222-153-2 EUDAMEDØ 2.0 x 15 mm EUDAMED220-153-2 EUDAMEDØ2.75 x 18 mm EUDAMED227-184-5 EUDAMEDØ 4.5 mm x 12 mm EUDAMED245-123-2 EUDAMEDØ 3.25 x 12 mm EUDAMED232-123-2 EUDAMEDØ 5.0 mm x 8 mm EUDAMED250-083-2 EUDAMEDØ 5.0 x 08 mm EUDAMED250-084-5 EUDAMEDØ1.75 x 18 mm EUDAMED217-184-5 EUDAMEDØ3.5 x 26 mm EUDAMED235-264-5 EUDAMEDØ 3.75 x 18 mm EUDAMED237-184-5 EUDAMEDØ2.875 x 15 mm EUDAMED228-154-5 EUDAMEDØ 3.25 x 8 mm EUDAMED232-083-2 EUDAMEDØ 4.0 x 12 mm EUDAMED240-123-2 EUDAMEDØ2.75 x 22 mm EUDAMED227-224-5 EUDAMEDØ2.0 x 18 mm EUDAMED220-184-5 EUDAMEDØ2.875 x 18 mm EUDAMED228-184-5 EUDAMEDØ1.5 x 26 mm EUDAMED215-264-5 EUDAMEDØ 3.75 x 22 mm EUDAMED237-224-5 EUDAMEDØ3.75 x 10 mm EUDAMED237-104-5 EUDAMEDØ2.25 x 08 mm EUDAMED222-084-5 EUDAMEDØ 4.5 mm x 18 mm EUDAMED245-183-2 EUDAMEDØ3.0 x 12 mm EUDAMED230-124-5 EUDAMEDØ 4.5 mm x 8 mm EUDAMED245-083-2 EUDAMEDØ 5.0 mm x 12 mm EUDAMED250-123-2 EUDAMEDØ 2.75 x 8 mm EUDAMED227-083-2 EUDAMEDØ 4.0 x 08 mm EUDAMED240-084-5 EUDAMEDØ 3.75 x 15 mm EUDAMED237-153-2 EUDAMEDØ2.25 x 18 mm EUDAMED222-184-5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08719244951178 EUDAMED08717853292972 EUDAMED08719244951598 EUDAMED08719244951321 EUDAMED08719244951987 EUDAMED08717853292606 EUDAMED08717853292705 EUDAMED08719244951932 EUDAMED08717853292873 EUDAMED08719244951307 EUDAMED08719244951130 EUDAMED08717853292712 EUDAMED08719244951642 EUDAMED08719244951208 EUDAMED08719244951413 EUDAMED08717853292552 EUDAMED08717853292644 EUDAMED08717853292859 EUDAMED08717853292736 EUDAMED08719244951895 EUDAMED08719244951970 EUDAMED08719244951406 EUDAMED08719244951765 EUDAMED08717853292613 EUDAMED08717853292569 EUDAMED08719244951437 EUDAMED08717853294280 EUDAMED08717853292804 EUDAMED08717853294310 EUDAMED08719244951956 EUDAMED08719244951154 EUDAMED08719244951734 EUDAMED08719244951789 EUDAMED08719244951499 EUDAMED08717853292781 EUDAMED08717853292958 EUDAMED08719244951444 EUDAMED08719244951222 EUDAMED08719244951505 EUDAMED08719244951109 EUDAMED08719244951796 EUDAMED08719244951758 EUDAMED08719244951253 EUDAMED08717853294303 EUDAMED08719244951550 EUDAMED08717853294266 EUDAMED08717853294334 EUDAMED08717853292682 EUDAMED08719244951819 EUDAMED08717853292910 EUDAMED08719244951291 EUDAMED
- Basic UDI-DI
- B-08719244951178 EUDAMEDB-08717853292972 EUDAMEDB-08719244951598 EUDAMEDB-08719244951321 EUDAMEDB-08719244951987 EUDAMEDB-08717853292606 EUDAMEDB-08717853292705 EUDAMEDB-08719244951932 EUDAMEDB-08717853292873 EUDAMEDB-08719244951307 EUDAMEDB-08719244951130 EUDAMEDB-08717853292712 EUDAMEDB-08719244951642 EUDAMEDB-08719244951208 EUDAMEDB-08719244951413 EUDAMEDB-08717853292552 EUDAMEDB-08717853292644 EUDAMEDB-08717853292859 EUDAMEDB-08717853292736 EUDAMEDB-08719244951895 EUDAMEDB-08719244951970 EUDAMEDB-08719244951406 EUDAMEDB-08719244951765 EUDAMEDB-08717853292613 EUDAMEDB-08717853292569 EUDAMEDB-08719244951437 EUDAMEDB-08717853294280 EUDAMEDB-08717853292804 EUDAMEDB-08717853294310 EUDAMEDB-08719244951956 EUDAMEDB-08719244951154 EUDAMEDB-08719244951734 EUDAMEDB-08719244951789 EUDAMEDB-08719244951499 EUDAMEDB-08717853292781 EUDAMEDB-08717853292958 EUDAMEDB-08719244951444 EUDAMEDB-08719244951222 EUDAMEDB-08719244951505 EUDAMEDB-08719244951109 EUDAMEDB-08719244951796 EUDAMEDB-08719244951758 EUDAMEDB-08719244951253 EUDAMEDB-08717853294303 EUDAMEDB-08719244951550 EUDAMEDB-08717853294266 EUDAMEDB-08717853294334 EUDAMEDB-08717853292682 EUDAMEDB-08719244951819 EUDAMEDB-08717853292910 EUDAMEDB-08719244951291 EUDAMED
- EMDN Code
- C010401020101 PTCA BALLOON DILATION CATHETERS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany EUDAMEDNetherlands 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 NC 24 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-08719244951178 | 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 (51)
- EUDAMED 0a80bf16-3533-4db6-97c2-145dee652eab 61 fields · synced Oct 6, 2026
- EUDAMED 2a36060b-d6a1-40a6-8714-1ff3792c953f 61 fields · synced May 11, 2026
- EUDAMED 6468b27d-8ced-4675-ac4d-f5b53549d6aa 61 fields · synced May 11, 2026
- EUDAMED f3aed513-52c0-469a-9576-4bb7ae096b23 61 fields · synced May 11, 2026
- EUDAMED ef779d81-2ac6-4adc-a639-3e8ab344b6e4 61 fields · synced May 16, 2026
- EUDAMED b396cf13-fa5d-462c-92f9-7611e71e89bd 61 fields · synced May 16, 2026
- EUDAMED d9f29134-3a1b-47af-a994-e9dc7d4f47f5 61 fields · synced May 16, 2026
- EUDAMED 46235dfb-266f-4d15-b52a-9b5654b516c4 61 fields · synced May 16, 2026
- EUDAMED cf56b43e-41e0-4788-921e-a51de338701d 61 fields · synced May 16, 2026
- EUDAMED 5e3b084b-4628-4a36-9716-af1ca791b220 61 fields · synced May 16, 2026
- EUDAMED a6d2aeab-31bb-4139-b264-e4cf3fc70139 61 fields · synced May 16, 2026
- EUDAMED e5c98a99-52a6-488c-8a3f-596437135f2b 61 fields · synced May 16, 2026
- EUDAMED 7cf2010c-7952-4b49-a63e-eadcfb192c17 61 fields · synced May 16, 2026
- EUDAMED 7dd922ba-1fea-45fb-b6e6-b60082f9fdf0 61 fields · synced May 16, 2026
- EUDAMED bd0af7dd-8aee-42e0-9fac-b5b7e2eef166 61 fields · synced May 16, 2026
- EUDAMED b93f0d06-84e2-44e4-a29e-835d583e6c70 61 fields · synced May 16, 2026
- EUDAMED 23a850da-e902-4d4f-82ae-06affb532ab3 61 fields · synced May 16, 2026
- EUDAMED 44261430-6d24-4028-be87-9cbfec57528c 61 fields · synced May 16, 2026
- EUDAMED 5fe9c95c-15cb-4b71-8c16-271df48c6543 61 fields · synced May 16, 2026
- EUDAMED 5ee98b57-739e-4a90-bc1c-14efbf119410 61 fields · synced May 17, 2026
- EUDAMED 8525f216-2c66-4320-9f3e-371856d92b0e 61 fields · synced May 17, 2026
- EUDAMED f6ba4c58-514c-4e55-a107-44ac59f8e83e 61 fields · synced May 17, 2026
- EUDAMED 55b03a21-6165-4710-9fee-79cdbd702a92 61 fields · synced May 17, 2026
- EUDAMED da5c89b9-4f12-41b3-9aa2-da2b80c6690f 61 fields · synced May 17, 2026
- EUDAMED a7044f06-526f-47e7-bdc4-acd8bf77dad2 61 fields · synced May 17, 2026
- EUDAMED 5286aca4-d1c9-47cd-b636-9ef147fb82f1 61 fields · synced May 17, 2026
- EUDAMED 3beffb12-5bcf-4b02-b027-87ce397b6759 61 fields · synced May 17, 2026
- EUDAMED e6dd811d-4042-47ba-ac79-a52c14f6f536 61 fields · synced May 17, 2026
- EUDAMED 0abfee14-29a1-47f0-b5a3-9261c55e422c 61 fields · synced May 17, 2026
- EUDAMED 2b712f3c-67a7-49b3-930b-4002bc83cc76 61 fields · synced May 17, 2026
- EUDAMED 54021c88-722a-480e-8f02-7e57c20aefd1 61 fields · synced May 17, 2026
- EUDAMED cde5a0df-dab1-4c52-ab32-b17836ec4599 61 fields · synced May 17, 2026
- EUDAMED 9d9d7a11-a8a0-4097-a97d-7c63f151d169 61 fields · synced May 17, 2026
- EUDAMED fa60833e-ca9e-431b-971d-aab5a5cdb3df 61 fields · synced May 17, 2026
- EUDAMED 6feda692-60bb-4d29-9097-88af696b855a 61 fields · synced May 17, 2026
- EUDAMED a72fa2b8-f82e-43cc-8c04-1e6fc0872caf 61 fields · synced May 17, 2026
- EUDAMED 3b98ce31-fdd6-4b74-aa7f-146dd91ba6f6 61 fields · synced May 17, 2026
- EUDAMED 7f8efbc1-e678-43a7-b331-21cb5aaa9155 61 fields · synced May 17, 2026
- EUDAMED c336f9c1-a8c0-43e0-a1ac-617259073234 61 fields · synced May 17, 2026
- EUDAMED 52e3c823-e9d4-43c9-b5d1-804d769bdc56 61 fields · synced May 17, 2026
- EUDAMED f19e4b5f-c359-4483-9c89-1dfa39d315a7 61 fields · synced May 17, 2026
- EUDAMED f80097d9-b7bd-4a27-baff-99f6a957c779 61 fields · synced May 18, 2026
- EUDAMED 439eb0e0-2665-4202-ba54-946355f4ba0e 61 fields · synced May 18, 2026
- EUDAMED b927b925-4496-4017-afa7-34c57aeab782 61 fields · synced May 18, 2026
- EUDAMED 9b39f282-3203-491b-8b34-d091b4e16b7a 61 fields · synced May 18, 2026
- EUDAMED fcc4a915-8439-40fe-b589-0bf5653b9e9c 61 fields · synced May 18, 2026
- EUDAMED 9608cafc-2522-456a-aaad-3340766327e9 61 fields · synced May 18, 2026
- EUDAMED cbd3a05b-f5a4-41df-aa08-18169eabf79c 61 fields · synced May 18, 2026
- EUDAMED 397667ad-5307-4ded-955e-2123e5c0d3fb 61 fields · synced May 18, 2026
- EUDAMED 3217ae44-34cd-465f-98ea-e1525844126f 61 fields · synced May 18, 2026
- EUDAMED 828f5b31-188d-4147-b616-4469fcf3ae03 61 fields · synced May 18, 2026