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Neon
EUDAMEDClass III (EU MDR)
Ref BS-40020Model Kaneka PTCA Balloon Dilatation CathetersRef BS-20010Ref BS-17508Ref BS-17510Ref BS-30006Ref BS-40012Ref BS-40010Ref BS-20018Ref BS-25030Ref BS-32520Ref BS-27518Ref BS-37512Ref BS-40015Ref BS-27510Ref BS-15018Ref BS-30015Ref BS-40008Ref BS-32518Ref BS-12006Ref BS-35020Ref BS-27530Ref BS-22515Ref BS-30030Ref BS-17515Ref BS-20008Ref BS-27515Ref BS-35012Ref BS-32508Ref BS-27520Ref BS-37508Ref BS-15015Ref BS-32515Ref BS-15012Ref BS-37515Ref BS-30008Ref BS-22510Ref BS-22506Ref BS-10006FRef BS-15030Ref BS-35008Ref BS-17506Ref BS-20030Ref BS-35030Ref BS-40030Ref BS-20006Ref BS-27512Ref BS-22508Ref BS-20020Ref BS-30018Ref BS-35006Ref BS-32510Ref BS-17518Ref BS-35015Ref BS-25008Ref BS-37510
Identity
- Trade Name
- NEON EUDAMED
- Device Name
- NEON EUDAMED
- Model / Reference
- Kaneka PTCA Balloon Dilatation Catheters EUDAMEDBS-40020 EUDAMEDBS-20010 EUDAMEDBS-17508 EUDAMEDBS-17510 EUDAMEDBS-30006 EUDAMEDBS-40012 EUDAMEDBS-40010 EUDAMEDBS-20018 EUDAMEDBS-25030 EUDAMEDBS-32520 EUDAMEDBS-27518 EUDAMEDBS-37512 EUDAMEDBS-40015 EUDAMEDBS-27510 EUDAMEDBS-15018 EUDAMEDBS-30015 EUDAMEDBS-40008 EUDAMEDBS-32518 EUDAMEDBS-12006 EUDAMEDBS-35020 EUDAMEDBS-27530 EUDAMEDBS-22515 EUDAMEDBS-30030 EUDAMEDBS-17515 EUDAMEDBS-20008 EUDAMEDBS-27515 EUDAMEDBS-35012 EUDAMEDBS-32508 EUDAMEDBS-27520 EUDAMEDBS-37508 EUDAMEDBS-15015 EUDAMEDBS-32515 EUDAMEDBS-15012 EUDAMEDBS-37515 EUDAMEDBS-30008 EUDAMEDBS-22510 EUDAMEDBS-22506 EUDAMEDBS-10006F EUDAMEDBS-15030 EUDAMEDBS-35008 EUDAMEDBS-17506 EUDAMEDBS-20030 EUDAMEDBS-35030 EUDAMEDBS-40030 EUDAMEDBS-20006 EUDAMEDBS-27512 EUDAMEDBS-22508 EUDAMEDBS-20020 EUDAMEDBS-30018 EUDAMEDBS-35006 EUDAMEDBS-32510 EUDAMEDBS-17518 EUDAMEDBS-35015 EUDAMEDBS-25008 EUDAMEDBS-37510 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04540778148420 EUDAMED04540778147904 EUDAMED04540778147782 EUDAMED04540778147898 EUDAMED04540778147690 EUDAMED04540778148093 EUDAMED04540778147980 EUDAMED04540778148239 EUDAMED04540778148475 EUDAMED04540778148390 EUDAMED04540778148260 EUDAMED04540778148086 EUDAMED04540778148208 EUDAMED04540778147935 EUDAMED04540778148215 EUDAMED04540778148161 EUDAMED04540778147874 EUDAMED04540778148284 EUDAMED04540778147621 EUDAMED04540778148406 EUDAMED04540778148482 EUDAMED04540778148130 EUDAMED04540778148499 EUDAMED04540778148116 EUDAMED04540778147799 EUDAMED04540778148154 EUDAMED04540778148079 EUDAMED04540778147843 EUDAMED04540778148376 EUDAMED04540778147867 EUDAMED04540778148109 EUDAMED04540778148178 EUDAMED04540778147997 EUDAMED04540778148192 EUDAMED04540778147836 EUDAMED04540778147911 EUDAMED04540778147669 EUDAMED04540778147607 EUDAMED04540778148437 EUDAMED04540778147850 EUDAMED04540778147645 EUDAMED04540778148451 EUDAMED04540778148512 EUDAMED04540778148536 EUDAMED04540778147652 EUDAMED04540778148048 EUDAMED04540778147805 EUDAMED04540778148345 EUDAMED04540778148277 EUDAMED04540778147713 EUDAMED04540778147959 EUDAMED04540778148222 EUDAMED04540778148185 EUDAMED04540778147812 EUDAMED04540778147973 EUDAMED
- Basic UDI-DI
- B-04540778148420 EUDAMEDB-04540778147904 EUDAMEDB-04540778147782 EUDAMEDB-04540778147898 EUDAMEDB-04540778147690 EUDAMEDB-04540778148093 EUDAMEDB-04540778147980 EUDAMEDB-04540778148239 EUDAMEDB-04540778148475 EUDAMEDB-04540778148390 EUDAMEDB-04540778148260 EUDAMEDB-04540778148086 EUDAMEDB-04540778148208 EUDAMEDB-04540778147935 EUDAMEDB-04540778148215 EUDAMEDB-04540778148161 EUDAMEDB-04540778147874 EUDAMEDB-04540778148284 EUDAMEDB-04540778147621 EUDAMEDB-04540778148406 EUDAMEDB-04540778148482 EUDAMEDB-04540778148130 EUDAMEDB-04540778148499 EUDAMEDB-04540778148116 EUDAMEDB-04540778147799 EUDAMEDB-04540778148154 EUDAMEDB-04540778148079 EUDAMEDB-04540778147843 EUDAMEDB-04540778148376 EUDAMEDB-04540778147867 EUDAMEDB-04540778148109 EUDAMEDB-04540778148178 EUDAMEDB-04540778147997 EUDAMEDB-04540778148192 EUDAMEDB-04540778147836 EUDAMEDB-04540778147911 EUDAMEDB-04540778147669 EUDAMEDB-04540778147607 EUDAMEDB-04540778148437 EUDAMEDB-04540778147850 EUDAMEDB-04540778147645 EUDAMEDB-04540778148451 EUDAMEDB-04540778148512 EUDAMEDB-04540778148536 EUDAMEDB-04540778147652 EUDAMEDB-04540778148048 EUDAMEDB-04540778147805 EUDAMEDB-04540778148345 EUDAMEDB-04540778148277 EUDAMEDB-04540778147713 EUDAMEDB-04540778147959 EUDAMEDB-04540778148222 EUDAMEDB-04540778148185 EUDAMEDB-04540778147812 EUDAMEDB-04540778147973 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Coronary angioplasty balloon catheter, cutting/scoring
Neon by KANEKA Corporation — 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-04540778148420 | Class III | Active |
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Manufacturer
- Manufacturer
- KANEKA Corporation
- EUDAMED SRN
- JP-MF-000022143
- Authorised Representative
- Kaneka Medical Europe N.V. BE-AR-000010091
Sources (55)
- EUDAMED 2068ba90-aaf8-4c20-82f8-8281d9cd754b 61 fields · synced Oct 1, 2026
- EUDAMED c390906a-cb3b-4f23-8814-5375301c903e 61 fields · synced May 11, 2026
- EUDAMED d8a13019-10d4-4f28-9339-a1df0db5f9fd 61 fields · synced May 11, 2026
- EUDAMED 0fd4f594-924a-4690-9213-41aff7f2fd63 61 fields · synced May 11, 2026
- EUDAMED 19d8c8c9-2895-4f22-ac81-b0d69aed0842 61 fields · synced May 11, 2026
- EUDAMED cb528cb0-e113-49a8-8f4a-e10e4fb669f4 61 fields · synced May 16, 2026
- EUDAMED f7b52a98-a807-404c-ba5c-180c1ebcd49c 61 fields · synced May 16, 2026
- EUDAMED ed74d66c-1e99-4b28-ae83-60439c161651 61 fields · synced May 16, 2026
- EUDAMED d40cf7ef-1dbf-4d41-a4fe-b05e132f0235 61 fields · synced May 16, 2026
- EUDAMED 84865ae7-9590-4ebe-9229-fddc67f15873 61 fields · synced May 16, 2026
- EUDAMED 38cee056-6a12-4dc3-b78e-11f6e6983a2c 61 fields · synced May 16, 2026
- EUDAMED 372e6c26-ce82-406c-8181-15dd219c83f1 61 fields · synced May 16, 2026
- EUDAMED 76bae239-e5fb-424c-bc3f-64aee74417ba 61 fields · synced May 16, 2026
- EUDAMED e1df190d-7bde-4d4f-bfaf-02893b71a230 61 fields · synced May 16, 2026
- EUDAMED c3ae6783-ad83-46c9-b1d0-96b932e97fe1 61 fields · synced May 16, 2026
- EUDAMED 7543947e-c3e7-4de0-91ad-77ec79fb3708 61 fields · synced May 17, 2026
- EUDAMED 8ec25ebc-1c79-4423-beb2-3860ff69902e 61 fields · synced May 17, 2026
- EUDAMED a77cf5aa-52e8-43d5-b9e3-2bb3e756191b 61 fields · synced May 17, 2026
- EUDAMED 0b0b7c79-192b-4658-aa1c-efe58a4c8e99 61 fields · synced May 17, 2026
- EUDAMED ac9f9738-2700-4bb0-86cf-c21e40bae007 61 fields · synced May 17, 2026
- EUDAMED a34b03c4-5e5e-4e03-8966-8198aa28b085 61 fields · synced May 17, 2026
- EUDAMED 032d44ef-652d-4dc5-afbd-6326a142f86e 61 fields · synced May 17, 2026
- EUDAMED f40a5b57-2045-4f1c-9f5d-02eb1973ff0c 61 fields · synced May 17, 2026
- EUDAMED b7406844-4dfa-4b33-99fb-2780140a255f 61 fields · synced May 17, 2026
- EUDAMED ecdabfce-6772-42c2-9944-65b9aa0214b9 61 fields · synced May 17, 2026
- EUDAMED bfc783e7-20dc-4d4c-b9a5-e50b25836365 61 fields · synced May 17, 2026
- EUDAMED 03f05af7-d975-4b27-bf7f-1f12caa54ddc 61 fields · synced May 17, 2026
- EUDAMED b4da66cc-acd9-4d20-a5af-958d7d82d4f0 61 fields · synced May 17, 2026
- EUDAMED b5db5c25-18a5-4465-b465-2ecb08e40c22 61 fields · synced May 17, 2026
- EUDAMED cba95193-9f0b-4bcb-9978-3da03f0ec00b 61 fields · synced May 17, 2026
- EUDAMED a49373dd-6876-43d7-9927-01f050ccd7f0 61 fields · synced May 18, 2026
- EUDAMED baaa4bb8-aaa4-4e13-9d5f-6bf5d07fd66e 61 fields · synced May 18, 2026
- EUDAMED 2aa7660f-7255-4b95-ace2-f0eaa63b529c 61 fields · synced May 18, 2026
- EUDAMED bd97791b-431e-499b-9491-5c02999c2144 61 fields · synced May 18, 2026
- EUDAMED d801acd5-b3ca-4017-8bf5-428f72c1bc8d 61 fields · synced May 18, 2026
- EUDAMED 3939c430-60ee-4742-b9d8-e824c567fda7 61 fields · synced May 18, 2026
- EUDAMED 5efe82a9-b148-4f0c-a86c-64c0cbd1e380 61 fields · synced May 18, 2026
- EUDAMED 20864f3c-eb28-4992-b4cb-b3ae3ea16688 61 fields · synced May 18, 2026
- EUDAMED 91e8ac4d-e2be-42bc-85f1-6dde70cb7ab6 61 fields · synced May 18, 2026
- EUDAMED 8824b4ea-fa47-4ae5-8386-3069cce35fb8 61 fields · synced May 18, 2026
- EUDAMED 56948704-cb92-4d4a-a045-426940fd9cd9 61 fields · synced May 18, 2026
- EUDAMED 960385ac-4b43-4bb5-88f4-d7410d2ecbf4 61 fields · synced May 18, 2026
- EUDAMED 876aadd3-8216-4be3-b430-80c213adf164 61 fields · synced May 18, 2026
- EUDAMED e6f205c6-d654-4b55-aa64-1ef7e71d2438 61 fields · synced May 18, 2026
- EUDAMED 8ab2f794-9134-4496-8eb1-5856ea68f093 61 fields · synced May 18, 2026
- EUDAMED 3fb67e76-e17d-457e-9046-3356459d0b2d 61 fields · synced May 18, 2026
- EUDAMED 79e57770-8a72-4920-88e1-dbcddb50d47d 61 fields · synced May 18, 2026
- EUDAMED 0b95385e-2679-4a89-8928-a52050b04f79 61 fields · synced May 18, 2026
- EUDAMED 8e906e1d-4d62-4e53-a698-b9edfc7f10bd 61 fields · synced May 19, 2026
- EUDAMED a25711f0-ab9b-44de-a83b-dca941740599 61 fields · synced May 19, 2026
- EUDAMED 19410dcc-e095-4c92-80d7-0f57ef1aa904 61 fields · synced May 19, 2026
- EUDAMED d422900d-20c3-41d0-b79f-ba6d5d91cf8c 61 fields · synced May 19, 2026
- EUDAMED 7aa23710-3b6b-4d31-926a-741c1e0cfaf6 61 fields · synced May 19, 2026
- EUDAMED 64166e8b-db53-404c-bba8-1ef68256f42e 61 fields · synced May 19, 2026
- EUDAMED d07e3f32-bbe5-4ee1-ae8d-fd9aea9464de 61 fields · synced May 19, 2026