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Sapphire 3

EUDAMED

Class III (EU MDR)

Ref 217-153-6Model Ø 1.75 x 15 mmRef 208-103-6Model Ø 0.85 x 10 mmRef 225-303-6Model Ø 2.5 x 30 mmRef 232-203-6Model Ø 3.25 x 20 mmRef 230-103-6Model Ø 3.0 x 10 mmRef 210-153-6Model Ø 1.0 x 15 mmRef 220-203-6Model Ø 2.0 x 20 mmRef 212-153-6Model Ø 1.25 x 15 mmRef 217-103-6Model Ø 1.75 x 10 mmRef 212-083-6Model Ø 1.25 x 8 mmRef 215-103-6Model Ø 1.5 x 10 mmRef 212-103-6Model Ø 1.25 x 10 mmRef 210-083-6Model Ø 1.0 x 8 mmRef 220-123-6Model Ø 2.0 x 12 mmRef 225-153-6Model Ø 2.5 x 15 mmRef 235-153-6Model Ø 3.5 x 15 mm Ref 232-153-6Model Ø 3.25 x 15 mmRef 240-103-6Model Ø 4.0 x 10 mmRef 227-153-6Model Ø 2.75 x 15 mmRef 215-203-6Model Ø 1.5 x 20 mmRef 227-203-6Model Ø 2.75 x 20 mmRef 222-203-6Model Ø 2.25 x 20 mmRef 212-053-6Model Ø 1.25 x 5 mmRef 215-123-6Model Ø 1.5 x 12 mmRef 227-103-6Model Ø 2.75 x 10 mmRef 235-103-6Model Ø 3.5 x 10 mm

by OrbusNeich Medical, B.V.

Identity

Trade Name
Sapphire 3 EUDAMED
Device Name
Sapphire 3 EUDAMED
Model / Reference
Ø 1.75 x 15 mm EUDAMED
217-153-6 EUDAMED
Ø 0.85 x 10 mm EUDAMED
208-103-6 EUDAMED
Ø 2.5 x 30 mm EUDAMED
225-303-6 EUDAMED
Ø 3.25 x 20 mm EUDAMED
232-203-6 EUDAMED
Ø 3.0 x 10 mm EUDAMED
230-103-6 EUDAMED
Ø 1.0 x 15 mm EUDAMED
210-153-6 EUDAMED
Ø 2.0 x 20 mm EUDAMED
220-203-6 EUDAMED
Ø 1.25 x 15 mm EUDAMED
212-153-6 EUDAMED
Ø 1.75 x 10 mm EUDAMED
217-103-6 EUDAMED
Ø 1.25 x 8 mm EUDAMED
212-083-6 EUDAMED
Ø 1.5 x 10 mm EUDAMED
215-103-6 EUDAMED
Ø 1.25 x 10 mm EUDAMED
212-103-6 EUDAMED
Ø 1.0 x 8 mm EUDAMED
210-083-6 EUDAMED
Ø 2.0 x 12 mm EUDAMED
220-123-6 EUDAMED
Ø 2.5 x 15 mm EUDAMED
225-153-6 EUDAMED
Ø 3.5 x 15 mm EUDAMED
235-153-6 EUDAMED
Ø 3.25 x 15 mm EUDAMED
232-153-6 EUDAMED
Ø 4.0 x 10 mm EUDAMED
240-103-6 EUDAMED
Ø 2.75 x 15 mm EUDAMED
227-153-6 EUDAMED
Ø 1.5 x 20 mm EUDAMED
215-203-6 EUDAMED
Ø 2.75 x 20 mm EUDAMED
227-203-6 EUDAMED
Ø 2.25 x 20 mm EUDAMED
222-203-6 EUDAMED
Ø 1.25 x 5 mm EUDAMED
212-053-6 EUDAMED
Ø 1.5 x 12 mm EUDAMED
215-123-6 EUDAMED
Ø 2.75 x 10 mm EUDAMED
227-103-6 EUDAMED
Ø 3.5 x 10 mm EUDAMED
235-103-6 EUDAMED

Identifiers

Primary DI / UDI-DI
08719244950720 EUDAMED
08719244950584 EUDAMED
08719244950850 EUDAMED
08719244950966 EUDAMED
08719244950898 EUDAMED
08719244950621 EUDAMED
08719244950775 EUDAMED
08719244950669 EUDAMED
08719244950713 EUDAMED
08719244950645 EUDAMED
08719244950676 EUDAMED
08719244950652 EUDAMED
08719244950607 EUDAMED
08719244950751 EUDAMED
08719244950836 EUDAMED
08719244950980 EUDAMED
08719244950959 EUDAMED
08719244951017 EUDAMED
08719244950874 EUDAMED
08719244950706 EUDAMED
08719244950881 EUDAMED
08719244950805 EUDAMED
08719244950638 EUDAMED
08719244950683 EUDAMED
08719244950867 EUDAMED
08719244950973 EUDAMED
Basic UDI-DI
B-08719244950720 EUDAMED
B-08719244950584 EUDAMED
B-08719244950850 EUDAMED
B-08719244950966 EUDAMED
B-08719244950898 EUDAMED
B-08719244950621 EUDAMED
B-08719244950775 EUDAMED
B-08719244950669 EUDAMED
B-08719244950713 EUDAMED
B-08719244950645 EUDAMED
B-08719244950676 EUDAMED
B-08719244950652 EUDAMED
B-08719244950607 EUDAMED
B-08719244950751 EUDAMED
B-08719244950836 EUDAMED
B-08719244950980 EUDAMED
B-08719244950959 EUDAMED
B-08719244951017 EUDAMED
B-08719244950874 EUDAMED
B-08719244950706 EUDAMED
B-08719244950881 EUDAMED
B-08719244950805 EUDAMED
B-08719244950638 EUDAMED
B-08719244950683 EUDAMED
B-08719244950867 EUDAMED
B-08719244950973 EUDAMED
EMDN Code
C010401020101 PTCA BALLOON DILATION CATHETERS EUDAMED

Classification

Device Class
Class III EUDAMED
Market of Registration
Spain 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

Sapphire 3 by OrbusNeich Medical, B.V. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

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Manufacturer

Manufacturer
OrbusNeich Medical, B.V.
EUDAMED SRN
NL-MF-000010907

Sources (26)

  • EUDAMED 1c9c433c-20c2-4ee9-8b17-77dabacffe1c 61 fields · synced Sep 18, 2026
  • EUDAMED 44fae08f-8a8d-4cc6-9a89-e9243a813d26 61 fields · synced May 11, 2026
  • EUDAMED a191be3d-93b3-49b6-ab87-b447a50c8bbd 61 fields · synced May 16, 2026
  • EUDAMED 4f315608-bb3f-4ab8-a4ab-4f621630a4d2 61 fields · synced May 16, 2026
  • EUDAMED daf3d55a-6bee-4653-b588-20afde2639e8 61 fields · synced May 16, 2026
  • EUDAMED 510d2bbf-fb54-42e0-a625-5e08deb75f0d 61 fields · synced May 16, 2026
  • EUDAMED f03462f9-6f34-414f-9f9a-42f933dabeab 61 fields · synced May 16, 2026
  • EUDAMED f38498d6-c2fc-40dd-838c-a4a72e7c564f 61 fields · synced May 16, 2026
  • EUDAMED 827b684c-0912-4ff0-a22e-652ff4b66b17 61 fields · synced May 17, 2026
  • EUDAMED 44719216-54f9-47ef-8d03-6b10408fee0a 61 fields · synced May 17, 2026
  • EUDAMED eb892879-99da-43b8-b3e4-7f9e7936e00e 61 fields · synced May 17, 2026
  • EUDAMED 12f40fbd-6d21-4bd2-9a17-54d6b52c2dc9 61 fields · synced May 17, 2026
  • EUDAMED 47ea8908-9c19-4d43-93e8-64cbf6cbf6ea 61 fields · synced May 17, 2026
  • EUDAMED 28555e34-c98e-4f5b-b2ea-297ed39ace27 61 fields · synced May 17, 2026
  • EUDAMED c99b97e5-270e-4810-8202-babf72b9449c 61 fields · synced May 17, 2026
  • EUDAMED 599efbad-f6df-4f05-ab3a-958b3f58d2d8 61 fields · synced May 18, 2026
  • EUDAMED 733802de-f39b-4ee6-b2a9-9d07dd750d6f 61 fields · synced May 18, 2026
  • EUDAMED 4c53fe58-ca2a-4c17-97aa-58238753e239 61 fields · synced May 18, 2026
  • EUDAMED 68341d13-d050-4614-af9c-ea0bd70b1439 61 fields · synced May 18, 2026
  • EUDAMED 028b965a-3cf1-4232-9c25-292e3a6bf726 61 fields · synced May 18, 2026
  • EUDAMED 1474be29-26a7-49dc-a741-e1b88bbb0c6a 61 fields · synced May 18, 2026
  • EUDAMED c1a8dc08-dfaa-4199-a523-0539506dc11b 61 fields · synced May 18, 2026
  • EUDAMED f9fb05be-53f7-45be-8257-a3f3537b787e 61 fields · synced May 19, 2026
  • EUDAMED 10f1b792-69ea-465e-a728-05f838401173 61 fields · synced May 19, 2026
  • EUDAMED a00750c0-d60f-4a6c-9ffb-87b31a72e565 61 fields · synced May 19, 2026
  • EUDAMED e126ba74-341b-4a62-bb18-c8b8dc41a842 61 fields · synced May 19, 2026