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Sapphire II PRO
EUDAMEDClass III (EU MDR)
Ref 220-103-5UModel Ø 2.0 x 10 mmRef 222-103-5UModel Ø 2.25 x 10 mmRef 232-153-5UModel Ø 3.25 x 15 mmRef 220-203-5UModel Ø 2.0 x 20 mmRef 222-153-5UModel Ø 2.25 x 15 mmRef 240-153-5UModel Ø 4.0 x 15 mmRef 240-103-5UModel Ø 4.0 x 10 mmRef 212-153-5UModel Ø 1.25 x 15 mmRef 217-153-5UModel Ø 1.75 x 15 mmRef 225-203-5UModel Ø 2.5 x 20 mmRef 217-103-5UModel Ø 1.75 x 10 mmRef 210-083-5UModel Ø 1.0 x 8 mmRef 240-203-5UModel Ø 4.0 x 20 mmRef 215-153-5UModel Ø 1.5 x 15 mmRef 215-123-5UModel Ø 1.5 x 12 mmRef 227-103-5UModel Ø 2.75 x 10 mmRef 212-053-5UModel Ø 1.25 x 5 mmRef 225-123-5UModel Ø 2.5 x 12 mmRef 227-153-5UModel Ø 2.75 x 15 mmRef 212-083-5UModel Ø 1.25 x 8 mmRef 225-153-5UModel Ø 2.5 x 15 mmRef 230-153-5UModel Ø 3.0 x 15 mmRef 235-153-5UModel Ø 3.5 x 15 mmRef 230-203-5UModel Ø 3.0 x 20 mmRef 215-103-5UModel Ø 1.5 x 10 mmRef 215-203-5UModel Ø 1.5 x 20 mmRef 210-103-5UModel Ø 1.0 x 10 mmRef 232-103-5UModel Ø 3.25 x 10 mmRef 225-303-5UModel Ø 2.5 x 30 mmRef 235-203-5UModel Ø 3.5 x 20 mmRef 220-123-5UModel Ø 2.0 x 12 mmRef 232-203-5UModel Ø 3.25 x 20 mmRef 210-153-5UModel Ø 1.0 x 15 mmRef 220-153-5UModel Ø 2.0 x 15 mm
Identity
- Trade Name
- Sapphire II PRO EUDAMED
- Device Name
- Sapphire II PRO EUDAMED
- Model / Reference
- Ø 2.0 x 10 mm EUDAMED220-103-5U EUDAMEDØ 2.25 x 10 mm EUDAMED222-103-5U EUDAMEDØ 3.25 x 15 mm EUDAMED232-153-5U EUDAMEDØ 2.0 x 20 mm EUDAMED220-203-5U EUDAMEDØ 2.25 x 15 mm EUDAMED222-153-5U EUDAMEDØ 4.0 x 15 mm EUDAMED240-153-5U EUDAMEDØ 4.0 x 10 mm EUDAMED240-103-5U EUDAMEDØ 1.25 x 15 mm EUDAMED212-153-5U EUDAMEDØ 1.75 x 15 mm EUDAMED217-153-5U EUDAMEDØ 2.5 x 20 mm EUDAMED225-203-5U EUDAMEDØ 1.75 x 10 mm EUDAMED217-103-5U EUDAMEDØ 1.0 x 8 mm EUDAMED210-083-5U EUDAMEDØ 4.0 x 20 mm EUDAMED240-203-5U EUDAMEDØ 1.5 x 15 mm EUDAMED215-153-5U EUDAMEDØ 1.5 x 12 mm EUDAMED215-123-5U EUDAMEDØ 2.75 x 10 mm EUDAMED227-103-5U EUDAMEDØ 1.25 x 5 mm EUDAMED212-053-5U EUDAMEDØ 2.5 x 12 mm EUDAMED225-123-5U EUDAMEDØ 2.75 x 15 mm EUDAMED227-153-5U EUDAMEDØ 1.25 x 8 mm EUDAMED212-083-5U EUDAMEDØ 2.5 x 15 mm EUDAMED225-153-5U EUDAMEDØ 3.0 x 15 mm EUDAMED230-153-5U EUDAMEDØ 3.5 x 15 mm EUDAMED235-153-5U EUDAMEDØ 3.0 x 20 mm EUDAMED230-203-5U EUDAMEDØ 1.5 x 10 mm EUDAMED215-103-5U EUDAMEDØ 1.5 x 20 mm EUDAMED215-203-5U EUDAMEDØ 1.0 x 10 mm EUDAMED210-103-5U EUDAMEDØ 3.25 x 10 mm EUDAMED232-103-5U EUDAMEDØ 2.5 x 30 mm EUDAMED225-303-5U EUDAMEDØ 3.5 x 20 mm EUDAMED235-203-5U EUDAMEDØ 2.0 x 12 mm EUDAMED220-123-5U EUDAMEDØ 3.25 x 20 mm EUDAMED232-203-5U EUDAMEDØ 1.0 x 15 mm EUDAMED210-153-5U EUDAMEDØ 2.0 x 15 mm EUDAMED220-153-5U EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08717853296697 EUDAMED08717853296734 EUDAMED08717853296901 EUDAMED08717853296727 EUDAMED08717853296741 EUDAMED08717853296970 EUDAMED08717853296963 EUDAMED08717853296611 EUDAMED08717853296673 EUDAMED08717853296796 EUDAMED08717853296666 EUDAMED08717853296550 EUDAMED08717853296987 EUDAMED08717853296642 EUDAMED08717853296635 EUDAMED08717853296819 EUDAMED08717853296581 EUDAMED08717853296772 EUDAMED08717853296826 EUDAMED08717853296598 EUDAMED08717853296789 EUDAMED08717853296864 EUDAMED08717853296932 EUDAMED08717853296871 EUDAMED08717853296628 EUDAMED08717853296659 EUDAMED08717853296567 EUDAMED08717853296895 EUDAMED08717853296802 EUDAMED08717853296949 EUDAMED08717853296703 EUDAMED08717853296918 EUDAMED08717853296574 EUDAMED08717853296710 EUDAMED
- Basic UDI-DI
- B-08717853296697 EUDAMEDB-08717853296734 EUDAMEDB-08717853296901 EUDAMEDB-08717853296727 EUDAMEDB-08717853296741 EUDAMEDB-08717853296970 EUDAMEDB-08717853296963 EUDAMEDB-08717853296611 EUDAMEDB-08717853296673 EUDAMEDB-08717853296796 EUDAMEDB-08717853296666 EUDAMEDB-08717853296550 EUDAMEDB-08717853296987 EUDAMEDB-08717853296642 EUDAMEDB-08717853296635 EUDAMEDB-08717853296819 EUDAMEDB-08717853296581 EUDAMEDB-08717853296772 EUDAMEDB-08717853296826 EUDAMEDB-08717853296598 EUDAMEDB-08717853296789 EUDAMEDB-08717853296864 EUDAMEDB-08717853296932 EUDAMEDB-08717853296871 EUDAMEDB-08717853296628 EUDAMEDB-08717853296659 EUDAMEDB-08717853296567 EUDAMEDB-08717853296895 EUDAMEDB-08717853296802 EUDAMEDB-08717853296949 EUDAMEDB-08717853296703 EUDAMEDB-08717853296918 EUDAMEDB-08717853296574 EUDAMEDB-08717853296710 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
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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-08717853296697 | 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 (34)
- EUDAMED 517dd40c-3a99-4ca7-9598-fbe07e386de3 61 fields · synced Oct 6, 2026
- EUDAMED cc2b49eb-ea0c-49c0-85f4-d943c689bd25 61 fields · synced May 11, 2026
- EUDAMED 28a6c588-c3ec-4b7d-b84a-8a4215e34b36 61 fields · synced May 16, 2026
- EUDAMED 15225640-75fc-45c6-9dbc-fb9129accd69 61 fields · synced May 16, 2026
- EUDAMED 2a82b562-020d-440e-bc94-d72377b8ae77 61 fields · synced May 16, 2026
- EUDAMED 85fed05b-9ea3-43b3-ad76-8564bbea8fe4 61 fields · synced May 17, 2026
- EUDAMED 3bc7584c-fd4e-4457-b2e3-c3495035bcc7 61 fields · synced May 17, 2026
- EUDAMED e5701a55-ae6b-49dd-b629-c4eae0c0c147 61 fields · synced May 17, 2026
- EUDAMED 169553e7-0bbc-4b37-a57c-ac5e8afe08a4 61 fields · synced May 17, 2026
- EUDAMED 0c52e18e-3612-46db-8fcc-410b88a54fd7 61 fields · synced May 17, 2026
- EUDAMED 5d8e86b6-0cd9-402f-b862-da8d3169ffff 61 fields · synced May 17, 2026
- EUDAMED b959dbf7-1bf4-42da-b25b-08aa23b9427b 61 fields · synced May 17, 2026
- EUDAMED 0eece2f3-ca59-4d2e-877e-ff0289b48131 61 fields · synced May 17, 2026
- EUDAMED 7b42b31f-ae81-49b4-a6ec-3eda8ee0b6a0 61 fields · synced May 17, 2026
- EUDAMED f0951550-7470-45b7-86fc-f9f77ad7576d 61 fields · synced May 17, 2026
- EUDAMED 820e1808-7883-4189-88ec-742b63d4ca8b 61 fields · synced May 17, 2026
- EUDAMED d06bbb39-9c5f-4116-83be-07da64b9e377 61 fields · synced May 17, 2026
- EUDAMED a286d6a7-01f7-476d-a636-b96dedfce226 61 fields · synced May 17, 2026
- EUDAMED 9bf9b19c-63b1-4b45-a0ea-17ebf6b94730 61 fields · synced May 17, 2026
- EUDAMED 70d8a986-89d0-4933-9f8d-eff10b1d5f20 61 fields · synced May 17, 2026
- EUDAMED 92e3ac4a-8f80-4162-a7ce-890ab6d793fb 61 fields · synced May 18, 2026
- EUDAMED f5114e85-85f0-46cd-be95-71e8a985277a 61 fields · synced May 18, 2026
- EUDAMED a21c2a18-6e64-4091-9073-14ce8b5cd692 61 fields · synced May 18, 2026
- EUDAMED 6876472a-9096-4da1-9674-71e1ed32a978 61 fields · synced May 18, 2026
- EUDAMED fdd84c88-7443-4fc7-a966-98278a7fd021 61 fields · synced May 18, 2026
- EUDAMED fd9350d3-28ba-48fe-b74d-76bf33f435d1 61 fields · synced May 18, 2026
- EUDAMED e2082c79-66c3-4746-9308-5c70e5b119c9 61 fields · synced May 18, 2026
- EUDAMED d9d10901-6199-4183-b91d-9dce91b026eb 61 fields · synced May 18, 2026
- EUDAMED 7316544d-cc16-4738-99d9-7ea6da21535f 61 fields · synced Jul 9, 2026
- EUDAMED 436365f0-bb1e-45af-8237-c29dfd247c2c 61 fields · synced Jul 13, 2026
- EUDAMED f44b0133-ff09-4203-b1ca-50a52e0c8238 61 fields · synced Jul 14, 2026
- EUDAMED 27713bd6-27de-451e-b9ae-241601aa88e5 61 fields · synced Jul 17, 2026
- EUDAMED 6ba137dd-51dd-4c6e-8eeb-85fc5e1377a3 61 fields · synced Jul 26, 2026
- EUDAMED 0c92ee9f-afe6-469a-b6a7-949dc1ea0fb9 61 fields · synced Aug 1, 2026