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NC Osier™
EUDAMEDClass III (EU MDR)
Ref CDC843860Ref CDC843854Ref CDC843851Ref CDC843876Ref CDC843832Ref CDC842848Ref CDC843842Ref CDC843823Ref CDC842827Ref CDC843868Ref CDC843881Ref CDC843862Ref CDC843848Ref CDC843838Ref CDC842833Ref CDC842818Ref CDC843871Ref CDC843824Ref CDC843882Ref CDC843865Ref CDC842828Ref CDC843847Ref CDC843813Ref CDC843879Ref CDC843801Ref CDC843840Ref CDC843850Ref CDC842823Ref CDC843805Ref CDC843841Ref CDC843816Ref CDC843820Ref CDC842838Ref CDC843812Ref CDC843857Ref CDC843853Ref CDC842826Ref CDC842855Ref CDC843825Ref CDC843803Ref CDC843859Ref CDC843861Ref CDC843880Ref CDC843806Ref CDC843878Ref CDC843872Ref CDC843819Ref CDC843904Ref CDC843897Ref CDC843927Ref CDC843913
Identity
- Trade Name
- NC Osier™ EUDAMED
- Device Name
- Balloon Dilatation Catheter EUDAMED
- Model / Reference
- CDC843860 EUDAMEDCDC843854 EUDAMEDCDC843851 EUDAMEDCDC843876 EUDAMEDCDC843832 EUDAMEDCDC842848 EUDAMEDCDC843842 EUDAMEDCDC843823 EUDAMEDCDC842827 EUDAMEDCDC843868 EUDAMEDCDC843881 EUDAMEDCDC843862 EUDAMEDCDC843848 EUDAMEDCDC843838 EUDAMEDCDC842833 EUDAMEDCDC842818 EUDAMEDCDC843871 EUDAMEDCDC843824 EUDAMEDCDC843882 EUDAMEDCDC843865 EUDAMEDCDC842828 EUDAMEDCDC843847 EUDAMEDCDC843813 EUDAMEDCDC843879 EUDAMEDCDC843801 EUDAMEDCDC843840 EUDAMEDCDC843850 EUDAMEDCDC842823 EUDAMEDCDC843805 EUDAMEDCDC843841 EUDAMEDCDC843816 EUDAMEDCDC843820 EUDAMEDCDC842838 EUDAMEDCDC843812 EUDAMEDCDC843857 EUDAMEDCDC843853 EUDAMEDCDC842826 EUDAMEDCDC842855 EUDAMEDCDC843825 EUDAMEDCDC843803 EUDAMEDCDC843859 EUDAMEDCDC843861 EUDAMEDCDC843880 EUDAMEDCDC843806 EUDAMEDCDC843878 EUDAMEDCDC843872 EUDAMEDCDC843819 EUDAMEDCDC843904 EUDAMEDCDC843897 EUDAMEDCDC843927 EUDAMEDCDC843913 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04251790238609 EUDAMED04251790238548 EUDAMED04251790238517 EUDAMED04251790238760 EUDAMED04251790238326 EUDAMED04251790228488 EUDAMED04251790238425 EUDAMED04251790238234 EUDAMED04251790228273 EUDAMED04251790238685 EUDAMED04251790238814 EUDAMED04251790238623 EUDAMED04251790238487 EUDAMED04251790238388 EUDAMED04251790228334 EUDAMED04251790228181 EUDAMED04251790238715 EUDAMED04251790238241 EUDAMED04251790238821 EUDAMED04251790238654 EUDAMED04251790228280 EUDAMED04251790238470 EUDAMED04251790238135 EUDAMED04251790238791 EUDAMED04251790238012 EUDAMED04251790238401 EUDAMED04251790238500 EUDAMED04251790228235 EUDAMED04251790238050 EUDAMED04251790238418 EUDAMED04251790238166 EUDAMED04251790238203 EUDAMED04251790228389 EUDAMED04251790238128 EUDAMED04251790238579 EUDAMED04251790238531 EUDAMED04251790228266 EUDAMED04251790228556 EUDAMED04251790238258 EUDAMED04251790238036 EUDAMED04251790238593 EUDAMED04251790238616 EUDAMED04251790238807 EUDAMED04251790238067 EUDAMED04251790238784 EUDAMED04251790238722 EUDAMED04251790238197 EUDAMED04251790239040 EUDAMED04251790238975 EUDAMED04251790239279 EUDAMED04251790239132 EUDAMED
- Basic UDI-DI
- B-04251790238609 EUDAMEDB-04251790238548 EUDAMEDB-04251790238517 EUDAMEDB-04251790238760 EUDAMEDB-04251790238326 EUDAMEDB-04251790228488 EUDAMEDB-04251790238425 EUDAMEDB-04251790238234 EUDAMEDB-04251790228273 EUDAMEDB-04251790238685 EUDAMEDB-04251790238814 EUDAMEDB-04251790238623 EUDAMEDB-04251790238487 EUDAMEDB-04251790238388 EUDAMEDB-04251790228334 EUDAMEDB-04251790228181 EUDAMEDB-04251790238715 EUDAMEDB-04251790238241 EUDAMEDB-04251790238821 EUDAMEDB-04251790238654 EUDAMEDB-04251790228280 EUDAMEDB-04251790238470 EUDAMEDB-04251790238135 EUDAMEDB-04251790238791 EUDAMEDB-04251790238012 EUDAMEDB-04251790238401 EUDAMEDB-04251790238500 EUDAMEDB-04251790228235 EUDAMEDB-04251790238050 EUDAMEDB-04251790238418 EUDAMEDB-04251790238166 EUDAMEDB-04251790238203 EUDAMEDB-04251790228389 EUDAMEDB-04251790238128 EUDAMEDB-04251790238579 EUDAMEDB-04251790238531 EUDAMEDB-04251790228266 EUDAMEDB-04251790228556 EUDAMEDB-04251790238258 EUDAMEDB-04251790238036 EUDAMEDB-04251790238593 EUDAMEDB-04251790238616 EUDAMEDB-04251790238807 EUDAMEDB-04251790238067 EUDAMEDB-04251790238784 EUDAMEDB-04251790238722 EUDAMEDB-04251790238197 EUDAMEDB-04251790239040 EUDAMEDB-04251790238975 EUDAMEDB-04251790239279 EUDAMEDB-04251790239132 EUDAMED
- EMDN Code
- C010401020101 PTCA BALLOON DILATION CATHETERS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Türkiye 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
NC Osier™ by SWL Medizin GmbH — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-04251790238609 | Class III | Active |
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Manufacturer
- Manufacturer
- SWL Medizin GmbH
- EUDAMED SRN
- DE-MF-000008000
Sources (51)
- EUDAMED d3f69fca-2d83-4628-8e4d-33f149ab0e5d 61 fields · synced Oct 6, 2026
- EUDAMED 0adff751-fc94-405d-89af-2f54bdfd9d2e 61 fields · synced May 16, 2026
- EUDAMED b6f10020-417a-4cde-85c7-0be2a2b6d186 61 fields · synced May 16, 2026
- EUDAMED 6889797f-99b1-4971-82eb-6b10eae3ef05 61 fields · synced May 16, 2026
- EUDAMED e5623095-4da1-41c0-b0a5-a82e6622702b 61 fields · synced May 16, 2026
- EUDAMED d31c1930-5a0c-4957-a30e-4a31fc4e6db5 61 fields · synced May 16, 2026
- EUDAMED 9b8d463c-66b0-4428-b41b-e67fe7369dde 61 fields · synced May 16, 2026
- EUDAMED bc4d9134-9cf6-4409-ba30-b2b0e4cf6906 61 fields · synced May 17, 2026
- EUDAMED f9a300f9-2044-4739-a0b0-7379049c51b6 61 fields · synced May 17, 2026
- EUDAMED 74aed849-507c-492c-a8fd-32c2e027889c 61 fields · synced May 17, 2026
- EUDAMED ef05dfb2-d868-4533-a884-7c3c2d352ad2 61 fields · synced May 17, 2026
- EUDAMED 0b2dac5e-a7e6-481d-916d-a857a06aae66 61 fields · synced May 17, 2026
- EUDAMED eb68492c-df02-4a8a-80e8-e455ed6c2bd4 61 fields · synced May 17, 2026
- EUDAMED bc7de110-7934-4140-93cd-a4844629e45b 61 fields · synced May 17, 2026
- EUDAMED 720b7337-21be-448a-a4cc-b6c15dcd995e 61 fields · synced May 17, 2026
- EUDAMED 5648470a-fd19-400f-848f-8aa6e956d88b 61 fields · synced May 17, 2026
- EUDAMED a26b7a48-395d-4b4f-ba67-403d6bc3f59e 61 fields · synced May 17, 2026
- EUDAMED 1320bd41-ba51-4477-8d26-0235aa9b1760 61 fields · synced May 17, 2026
- EUDAMED a7c4f437-08d3-423f-b1aa-495a7da4b614 61 fields · synced May 17, 2026
- EUDAMED cad64b91-e14b-4183-97c0-744b3af0efbf 61 fields · synced May 17, 2026
- EUDAMED caf60243-a5a2-4287-b330-f1142937b409 61 fields · synced May 17, 2026
- EUDAMED 4db5b64e-dc21-4df1-9966-79e02cd8b2a0 61 fields · synced May 17, 2026
- EUDAMED f31a6635-349c-44d2-ae11-69fb1f070973 61 fields · synced May 17, 2026
- EUDAMED e010867c-eb01-4a19-a877-6b9c81e10841 61 fields · synced May 18, 2026
- EUDAMED 5064c8f7-d79e-4f70-9ab6-dc3a2caeb7f0 61 fields · synced May 18, 2026
- EUDAMED dbba2083-de81-4aa3-9b7e-b0d51a04ac9d 61 fields · synced May 18, 2026
- EUDAMED 9da15078-5ce9-4959-83fa-7f1c0731ffac 61 fields · synced May 18, 2026
- EUDAMED 7cd501da-357c-48ef-80ff-01cb4185185f 61 fields · synced May 18, 2026
- EUDAMED ccecb80f-552b-4418-9041-44b778c64312 61 fields · synced May 18, 2026
- EUDAMED eebede6c-e01d-4cfa-8696-dc50976c2537 61 fields · synced May 18, 2026
- EUDAMED f4b59e45-a71a-492d-b9e6-9726746cdc63 61 fields · synced May 18, 2026
- EUDAMED ab9cf106-630f-4ab6-9db5-d6e358092e5b 61 fields · synced May 18, 2026
- EUDAMED b011e3d6-a8dc-43d9-95c4-91556c018459 61 fields · synced May 18, 2026
- EUDAMED f8b86f89-1e32-4789-94ef-7903bb552f82 61 fields · synced May 18, 2026
- EUDAMED 9fb8c35a-7c85-48da-9672-206253d0515b 61 fields · synced May 18, 2026
- EUDAMED 4c148d6f-d6e4-425f-8c89-f11ce820acc1 61 fields · synced May 18, 2026
- EUDAMED d721eb6b-923e-4d5c-9f5d-bd73a4e5c613 61 fields · synced May 18, 2026
- EUDAMED 7ebd1ef8-22e3-4f55-a0b4-307a333c23f9 61 fields · synced May 18, 2026
- EUDAMED 631c172f-2b76-49aa-911f-b45c6249cbff 61 fields · synced May 18, 2026
- EUDAMED 717dd0e4-319d-4263-a6ed-7c6bbccc297a 61 fields · synced May 18, 2026
- EUDAMED 7b0a66a7-c772-4beb-b968-065bf98ce111 61 fields · synced May 19, 2026
- EUDAMED f1a3a179-a556-42e1-b530-fb11369f812a 61 fields · synced May 19, 2026
- EUDAMED 475cce06-7caf-41cc-9305-37dc29d074cb 61 fields · synced May 19, 2026
- EUDAMED 4314540d-da85-43df-ac2b-2b75b266f610 61 fields · synced May 19, 2026
- EUDAMED 9afcd3c2-7984-4105-912e-96329e97cdc7 61 fields · synced May 19, 2026
- EUDAMED ac5b8d18-11f6-4a30-8dbc-44962a515eee 61 fields · synced May 19, 2026
- EUDAMED 2d39bd02-77d1-4613-81eb-e2d5061ce86a 61 fields · synced May 19, 2026
- EUDAMED 8dc51889-0865-4252-8cb6-4618d19742f6 61 fields · synced Jun 20, 2026
- EUDAMED 88696071-e6ae-4fe3-8152-495f53a14c7f 61 fields · synced Jul 8, 2026
- EUDAMED 4dbf631a-3a07-46fd-a7bd-662cc17042d5 61 fields · synced Jul 10, 2026
- EUDAMED c24f25ab-acb7-446e-a448-f89e5991e7be 61 fields · synced Jul 11, 2026