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Balloon Dilatation Catheter
EUDAMEDClass III (EU MDR)
Ref BDC842829Ref BDC842861Ref BDC842905Ref BDC842867Ref BDC842814Ref BDC842846Ref BDC842805Ref BDC842819Ref BDC842904Ref BDC842834Ref BDC842894Ref BDC842944Ref BDC842847Ref BDC842857Ref BDC842949Ref BDC842886Ref BDC842804Ref BDC842954Ref BDC842943Ref BDC842806Ref BDC842871Ref BDC842807Ref BDC842866Ref BDC842845Ref BDC842907Ref BDC842947Ref BDC842853Ref BDC842831Ref BDC842836Ref BDC842811Ref BDC842897Ref BDC842950Ref BDC842808Ref BDC842885Ref BDC842840Ref BDC842824Ref BDC842862Ref BDC842815Ref BDC842852Ref BDC842898Ref BDC842946Ref BDC842821Ref BDC842873Ref BDC842948Ref BDC842802Ref BDC842958Ref BDC842989Ref BDC842959Ref BDC842962Ref BDC842975Ref BDC842961
Identity
- Device Name
- Balloon Dilatation Catheter EUDAMED
- Model / Reference
- BDC842829 EUDAMEDBDC842861 EUDAMEDBDC842905 EUDAMEDBDC842867 EUDAMEDBDC842814 EUDAMEDBDC842846 EUDAMEDBDC842805 EUDAMEDBDC842819 EUDAMEDBDC842904 EUDAMEDBDC842834 EUDAMEDBDC842894 EUDAMEDBDC842944 EUDAMEDBDC842847 EUDAMEDBDC842857 EUDAMEDBDC842949 EUDAMEDBDC842886 EUDAMEDBDC842804 EUDAMEDBDC842954 EUDAMEDBDC842943 EUDAMEDBDC842806 EUDAMEDBDC842871 EUDAMEDBDC842807 EUDAMEDBDC842866 EUDAMEDBDC842845 EUDAMEDBDC842907 EUDAMEDBDC842947 EUDAMEDBDC842853 EUDAMEDBDC842831 EUDAMEDBDC842836 EUDAMEDBDC842811 EUDAMEDBDC842897 EUDAMEDBDC842950 EUDAMEDBDC842808 EUDAMEDBDC842885 EUDAMEDBDC842840 EUDAMEDBDC842824 EUDAMEDBDC842862 EUDAMEDBDC842815 EUDAMEDBDC842852 EUDAMEDBDC842898 EUDAMEDBDC842946 EUDAMEDBDC842821 EUDAMEDBDC842873 EUDAMEDBDC842948 EUDAMEDBDC842802 EUDAMEDBDC842958 EUDAMEDBDC842989 EUDAMEDBDC842959 EUDAMEDBDC842962 EUDAMEDBDC842975 EUDAMEDBDC842961 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04251790228297 EUDAMED04251790228617 EUDAMED04251790229058 EUDAMED04251790228679 EUDAMED04251790228143 EUDAMED04251790228464 EUDAMED04251790228051 EUDAMED04251790228198 EUDAMED04251790229041 EUDAMED04251790228341 EUDAMED04251790228945 EUDAMED04251790229447 EUDAMED04251790228471 EUDAMED04251790228570 EUDAMED04251790229492 EUDAMED04251790228860 EUDAMED04251790228044 EUDAMED04251790229546 EUDAMED04251790229430 EUDAMED04251790228068 EUDAMED04251790228716 EUDAMED04251790228075 EUDAMED04251790228662 EUDAMED04251790228457 EUDAMED04251790229072 EUDAMED04251790229478 EUDAMED04251790228532 EUDAMED04251790228310 EUDAMED04251790228365 EUDAMED04251790228112 EUDAMED04251790228976 EUDAMED04251790229508 EUDAMED04251790228082 EUDAMED04251790228853 EUDAMED04251790228402 EUDAMED04251790228242 EUDAMED04251790228624 EUDAMED04251790228150 EUDAMED04251790228525 EUDAMED04251790228983 EUDAMED04251790229461 EUDAMED04251790228211 EUDAMED04251790228730 EUDAMED04251790229485 EUDAMED04251790228020 EUDAMED04251790229584 EUDAMED04251790229898 EUDAMED04251790229591 EUDAMED04251790229621 EUDAMED04251790229751 EUDAMED04251790229614 EUDAMED
- Basic UDI-DI
- B-04251790228297 EUDAMEDB-04251790228617 EUDAMEDB-04251790229058 EUDAMEDB-04251790228679 EUDAMEDB-04251790228143 EUDAMEDB-04251790228464 EUDAMEDB-04251790228051 EUDAMEDB-04251790228198 EUDAMEDB-04251790229041 EUDAMEDB-04251790228341 EUDAMEDB-04251790228945 EUDAMEDB-04251790229447 EUDAMEDB-04251790228471 EUDAMEDB-04251790228570 EUDAMEDB-04251790229492 EUDAMEDB-04251790228860 EUDAMEDB-04251790228044 EUDAMEDB-04251790229546 EUDAMEDB-04251790229430 EUDAMEDB-04251790228068 EUDAMEDB-04251790228716 EUDAMEDB-04251790228075 EUDAMEDB-04251790228662 EUDAMEDB-04251790228457 EUDAMEDB-04251790229072 EUDAMEDB-04251790229478 EUDAMEDB-04251790228532 EUDAMEDB-04251790228310 EUDAMEDB-04251790228365 EUDAMEDB-04251790228112 EUDAMEDB-04251790228976 EUDAMEDB-04251790229508 EUDAMEDB-04251790228082 EUDAMEDB-04251790228853 EUDAMEDB-04251790228402 EUDAMEDB-04251790228242 EUDAMEDB-04251790228624 EUDAMEDB-04251790228150 EUDAMEDB-04251790228525 EUDAMEDB-04251790228983 EUDAMEDB-04251790229461 EUDAMEDB-04251790228211 EUDAMEDB-04251790228730 EUDAMEDB-04251790229485 EUDAMEDB-04251790228020 EUDAMEDB-04251790229584 EUDAMEDB-04251790229898 EUDAMEDB-04251790229591 EUDAMEDB-04251790229621 EUDAMEDB-04251790229751 EUDAMEDB-04251790229614 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
Balloon Dilatation Catheter by SWL Medizin GmbH — 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-04251790228297 | Class III | Active |
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Manufacturer
- Manufacturer
- SWL Medizin GmbH
- EUDAMED SRN
- DE-MF-000008000
Sources (51)
- EUDAMED f2798ae9-cd1d-4ffc-917b-c5ed4ecdfe2f 61 fields · synced Oct 6, 2026
- EUDAMED 178dcd8f-e37e-4d1e-8979-84a1d864043f 61 fields · synced May 11, 2026
- EUDAMED 8e38ae94-f084-494f-a876-179658e67ab4 61 fields · synced May 16, 2026
- EUDAMED 0019f9b9-b226-45ce-a1ce-5e4f5a2c785f 61 fields · synced May 16, 2026
- EUDAMED 4c3f3ade-a3f0-4d9a-909a-564643ee0b97 61 fields · synced May 16, 2026
- EUDAMED 040d01cc-6880-470c-8470-6ec04b68736a 61 fields · synced May 16, 2026
- EUDAMED bde9db99-6fe0-406f-aa2d-18eb9c05025f 61 fields · synced May 16, 2026
- EUDAMED 81beb7ce-b52a-49a9-bdca-69edfedf2bc2 61 fields · synced May 16, 2026
- EUDAMED 40f4f8cd-694b-4721-9b19-281d8b61846f 61 fields · synced May 16, 2026
- EUDAMED 9fa3adbd-5f27-41c8-85e3-fc2d5636a5dd 61 fields · synced May 16, 2026
- EUDAMED e339e942-733b-4518-810b-4666e4874a40 61 fields · synced May 16, 2026
- EUDAMED 33019e2a-ba8a-48b2-a9d4-b671efa02641 61 fields · synced May 16, 2026
- EUDAMED 1e0365fd-31b5-4a9a-8eaa-b4cd4013c072 61 fields · synced May 17, 2026
- EUDAMED a5696ce5-2fb6-4341-9de9-d2a5f2cbef92 61 fields · synced May 17, 2026
- EUDAMED f47ccc8d-595e-4e61-9acc-c56ee06cc549 61 fields · synced May 17, 2026
- EUDAMED be065c48-e6ee-4a47-b244-2d7e8b8c1c70 61 fields · synced May 17, 2026
- EUDAMED c3ae7a0e-a504-4610-87ea-cd5e8b9faf3a 61 fields · synced May 17, 2026
- EUDAMED 6e473f42-f676-4209-9cc2-0630d406bbf6 61 fields · synced May 17, 2026
- EUDAMED 88680962-79c0-46ce-a331-02207d0521c2 61 fields · synced May 17, 2026
- EUDAMED 567e2e0e-679d-4a30-b17c-0431aabd1947 61 fields · synced May 17, 2026
- EUDAMED cf883324-085e-4296-af67-5b220a56cbe9 61 fields · synced May 17, 2026
- EUDAMED 25b1d4bd-a9c0-4c06-bec0-23eb90e82afd 61 fields · synced May 17, 2026
- EUDAMED b3c42b2b-0155-4752-a4de-f827b88bd42e 61 fields · synced May 17, 2026
- EUDAMED 4a060eca-cb18-46be-bda1-72a7a23d5b9f 61 fields · synced May 17, 2026
- EUDAMED ff9a96be-c946-4816-b28c-c8e21e04ff6d 61 fields · synced May 18, 2026
- EUDAMED e7c529ac-5777-4de2-b5c3-a8fa8d1dd173 61 fields · synced May 18, 2026
- EUDAMED f7cbafc0-b4dd-41a9-b057-1da5a278d5b2 61 fields · synced May 18, 2026
- EUDAMED 66550335-dd7b-46ca-9b83-8bc76a5cc965 61 fields · synced May 18, 2026
- EUDAMED af35af1a-570a-45d8-8ea7-7cecc6b84456 61 fields · synced May 18, 2026
- EUDAMED 1c408676-1f1e-4159-8464-3ad9a9ea632d 61 fields · synced May 18, 2026
- EUDAMED df6bbefd-ba78-4f69-8d0a-43567ea3d429 61 fields · synced May 18, 2026
- EUDAMED ac2a6aea-8f1b-40a7-b4e4-c17fa98c54e4 61 fields · synced May 18, 2026
- EUDAMED e03737e3-3010-4485-8075-a1e4f182d6b2 61 fields · synced May 18, 2026
- EUDAMED 7435d4c0-06d8-47fb-ba7d-958288a7614e 61 fields · synced May 18, 2026
- EUDAMED 573ed8be-235a-43b0-bed4-298a4e298259 61 fields · synced May 18, 2026
- EUDAMED 4787747e-4b1b-47cf-8b08-ee2211bd252e 61 fields · synced May 18, 2026
- EUDAMED 9d08eb87-52b1-42a0-bca6-05e2a569b0bc 61 fields · synced May 18, 2026
- EUDAMED daac2ae1-ce28-4e13-99f6-38cc717bb9a5 61 fields · synced May 18, 2026
- EUDAMED c3890cd9-2b74-42a1-a12c-1dcce2cf8ef1 61 fields · synced May 19, 2026
- EUDAMED 2e8b4c2c-76cd-4b1d-afa2-1c6db7201e56 61 fields · synced May 19, 2026
- EUDAMED 3b68c265-d6dd-47ca-9289-7e455a67ef21 61 fields · synced May 19, 2026
- EUDAMED a4dc88f6-524f-4181-87b7-f72ba4458ff6 61 fields · synced May 19, 2026
- EUDAMED 3e44dfab-fe1d-4744-883e-f7ce2562fb80 61 fields · synced May 19, 2026
- EUDAMED ca5fb3a4-1002-440b-8d91-eedb818fe6ef 61 fields · synced May 19, 2026
- EUDAMED 6a43fd8a-aa71-419d-b53c-1cf9eb944351 61 fields · synced May 19, 2026
- EUDAMED b93b98b1-c498-4762-9f50-3602f7d314ee 61 fields · synced Jul 9, 2026
- EUDAMED 76c81cfd-2f93-437d-bcc7-b6fdddc3f3c2 61 fields · synced Jul 9, 2026
- EUDAMED 21b20191-6615-47bd-948c-033f92ed205f 61 fields · synced Jul 11, 2026
- EUDAMED dbeb63b0-7271-4192-932f-a87467d82681 61 fields · synced Jul 11, 2026
- EUDAMED 32c8006d-ae54-4250-afee-eb1c68ad05fe 61 fields · synced Jul 11, 2026
- EUDAMED 9d5be516-acee-43fe-88a2-6b4785894623 61 fields · synced Jul 12, 2026