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Neon Nc

EUDAMED

Class III (EU MDR)

Ref BN-27513Model Kaneka PTCA Balloon Dilatation CathetersRef BN-35010Ref BN-42510Ref BN-32508Ref BN-45010Ref BN-20030Ref BN-27530Ref BN-25018Ref BN-22510Ref BN-45020Ref BN-35008Ref BN-20008Ref BN-40020Ref BN-40030Ref BN-32513Ref BN-27518Ref BN-40013Ref BN-45030Ref BN-22508Ref BN-42518Ref BN-37508Ref BN-37513Ref BN-27520Ref BN-20010Ref BN-42513Ref BN-32510Ref BN-35015Ref BN-20018Ref BN-42530Ref BN-37510Ref BN-30020Ref BN-35030Ref BN-45015Ref BN-25013Ref BN-30010Ref BN-15008Ref BN-22530Ref BN-45013Ref BN-30018Ref BN-25030Ref BN-22520Ref BN-40008

by KANEKA Corporation

Identity

Trade Name
NEON NC EUDAMED
Device Name
NEON NC EUDAMED
Model / Reference
Kaneka PTCA Balloon Dilatation Catheters EUDAMED
BN-27513 EUDAMED
BN-35010 EUDAMED
BN-42510 EUDAMED
BN-32508 EUDAMED
BN-45010 EUDAMED
BN-20030 EUDAMED
BN-27530 EUDAMED
BN-25018 EUDAMED
BN-22510 EUDAMED
BN-45020 EUDAMED
BN-35008 EUDAMED
BN-20008 EUDAMED
BN-40020 EUDAMED
BN-40030 EUDAMED
BN-32513 EUDAMED
BN-27518 EUDAMED
BN-40013 EUDAMED
BN-45030 EUDAMED
BN-22508 EUDAMED
BN-42518 EUDAMED
BN-37508 EUDAMED
BN-37513 EUDAMED
BN-27520 EUDAMED
BN-20010 EUDAMED
BN-42513 EUDAMED
BN-32510 EUDAMED
BN-35015 EUDAMED
BN-20018 EUDAMED
BN-42530 EUDAMED
BN-37510 EUDAMED
BN-30020 EUDAMED
BN-35030 EUDAMED
BN-45015 EUDAMED
BN-25013 EUDAMED
BN-30010 EUDAMED
BN-15008 EUDAMED
BN-22530 EUDAMED
BN-45013 EUDAMED
BN-30018 EUDAMED
BN-25030 EUDAMED
BN-22520 EUDAMED
BN-40008 EUDAMED

Identifiers

Primary DI / UDI-DI
04540778148819 EUDAMED
04540778148734 EUDAMED
04540778148765 EUDAMED
04540778148611 EUDAMED
04540778148772 EUDAMED
04540778149229 EUDAMED
04540778149250 EUDAMED
04540778149021 EUDAMED
04540778148680 EUDAMED
04540778149212 EUDAMED
04540778148628 EUDAMED
04540778148567 EUDAMED
04540778149199 EUDAMED
04540778149304 EUDAMED
04540778148833 EUDAMED
04540778149038 EUDAMED
04540778148864 EUDAMED
04540778149328 EUDAMED
04540778148574 EUDAMED
04540778149090 EUDAMED
04540778148635 EUDAMED
04540778148857 EUDAMED
04540778149144 EUDAMED
04540778148673 EUDAMED
04540778148871 EUDAMED
04540778148727 EUDAMED
04540778148956 EUDAMED
04540778149007 EUDAMED
04540778149311 EUDAMED
04540778148741 EUDAMED
04540778149151 EUDAMED
04540778149281 EUDAMED
04540778148994 EUDAMED
04540778148802 EUDAMED
04540778148710 EUDAMED
04540778148543 EUDAMED
04540778149236 EUDAMED
04540778148888 EUDAMED
04540778149045 EUDAMED
04540778149243 EUDAMED
04540778149120 EUDAMED
04540778148642 EUDAMED
Basic UDI-DI
B-04540778148819 EUDAMED
B-04540778148734 EUDAMED
B-04540778148765 EUDAMED
B-04540778148611 EUDAMED
B-04540778148772 EUDAMED
B-04540778149229 EUDAMED
B-04540778149250 EUDAMED
B-04540778149021 EUDAMED
B-04540778148680 EUDAMED
B-04540778149212 EUDAMED
B-04540778148628 EUDAMED
B-04540778148567 EUDAMED
B-04540778149199 EUDAMED
B-04540778149304 EUDAMED
B-04540778148833 EUDAMED
B-04540778149038 EUDAMED
B-04540778148864 EUDAMED
B-04540778149328 EUDAMED
B-04540778148574 EUDAMED
B-04540778149090 EUDAMED
B-04540778148635 EUDAMED
B-04540778148857 EUDAMED
B-04540778149144 EUDAMED
B-04540778148673 EUDAMED
B-04540778148871 EUDAMED
B-04540778148727 EUDAMED
B-04540778148956 EUDAMED
B-04540778149007 EUDAMED
B-04540778149311 EUDAMED
B-04540778148741 EUDAMED
B-04540778149151 EUDAMED
B-04540778149281 EUDAMED
B-04540778148994 EUDAMED
B-04540778148802 EUDAMED
B-04540778148710 EUDAMED
B-04540778148543 EUDAMED
B-04540778149236 EUDAMED
B-04540778148888 EUDAMED
B-04540778149045 EUDAMED
B-04540778149243 EUDAMED
B-04540778149120 EUDAMED
B-04540778148642 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 Nc by KANEKA Corporation — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Coronary angioplasty balloon catheter, cutting/scoring.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
KANEKA Corporation
EUDAMED SRN
JP-MF-000022143
Authorised Representative
Kaneka Medical Europe N.V. BE-AR-000010091

Sources (42)

  • EUDAMED 08b41d29-4bde-4524-a1db-4ef598c21b74 61 fields · synced Sep 17, 2026
  • EUDAMED 99e6e0d2-a68f-4201-8db3-0387c89ec746 61 fields · synced May 11, 2026
  • EUDAMED a02a489c-3f4e-49b8-b329-93ad4568617e 61 fields · synced May 11, 2026
  • EUDAMED aae496ec-b815-4e68-8622-eb4ab726a394 61 fields · synced May 11, 2026
  • EUDAMED 12b5e373-4713-4a55-b81f-8f91bae396bf 61 fields · synced May 11, 2026
  • EUDAMED e94d6c91-15f4-47be-a295-321c17a332a8 61 fields · synced May 16, 2026
  • EUDAMED d2b5715e-caf6-47ba-92ea-7b2c1a456e5d 61 fields · synced May 16, 2026
  • EUDAMED 40b3fd2a-b362-4894-b32b-e8ca0a770637 61 fields · synced May 16, 2026
  • EUDAMED 44865dd3-a987-4bf9-90ae-8476cae93215 61 fields · synced May 16, 2026
  • EUDAMED ba259d51-a170-41bc-a371-380e5043e043 61 fields · synced May 16, 2026
  • EUDAMED e8304637-b297-4bda-b69b-6c4ba21171df 61 fields · synced May 16, 2026
  • EUDAMED 828ab85e-98e1-442f-82ce-0f19b3c76cf4 61 fields · synced May 16, 2026
  • EUDAMED a73ccf47-2943-48b0-b308-264905764217 61 fields · synced May 16, 2026
  • EUDAMED f285c87b-ce6b-4446-91d3-9afc594c83e1 61 fields · synced May 16, 2026
  • EUDAMED cef3041f-f3b1-4c84-b3aa-e7f1e9a1b635 61 fields · synced May 17, 2026
  • EUDAMED eb717f68-3ca5-4190-b782-fb22c04bd380 61 fields · synced May 17, 2026
  • EUDAMED deea8a21-c92b-4058-aa93-5a4f8d5af956 61 fields · synced May 17, 2026
  • EUDAMED 39d7a219-9b0d-43f6-8dcc-cbf7b6148dcc 61 fields · synced May 17, 2026
  • EUDAMED 94bf11e2-01bd-4fef-9810-13400294eec2 61 fields · synced May 17, 2026
  • EUDAMED 3153672b-b6f9-40dc-a972-75bfa5f5a8cc 61 fields · synced May 17, 2026
  • EUDAMED f7cb28f7-fc02-4f4b-801b-e9a3a11808fb 61 fields · synced May 18, 2026
  • EUDAMED 35f6a87d-b85b-4843-9450-06ac131955c5 61 fields · synced May 18, 2026
  • EUDAMED 6461c9d2-1a6d-45e1-b9a1-5337790fcaed 61 fields · synced May 18, 2026
  • EUDAMED e6effe51-42a1-415b-a140-d1317320a218 61 fields · synced May 18, 2026
  • EUDAMED 5cb104d2-9a56-402f-b980-ca1a191b32ee 61 fields · synced May 18, 2026
  • EUDAMED c7aeb921-2b7d-475b-b8f2-134c9cbba202 61 fields · synced May 18, 2026
  • EUDAMED f5028fba-9418-40f1-9d9b-e200a2549104 61 fields · synced May 18, 2026
  • EUDAMED cb0607b5-8b59-4a1e-8fc6-9fbdad85b7c4 61 fields · synced May 18, 2026
  • EUDAMED 09880f7a-71fb-43d6-9d0b-4ddecc86953a 61 fields · synced May 18, 2026
  • EUDAMED a4c38d3f-f0a4-461d-af5d-03c44e110f93 61 fields · synced May 18, 2026
  • EUDAMED a48d9800-9282-4e0d-8a81-ae426dbca6a6 61 fields · synced May 18, 2026
  • EUDAMED 2f82e6c3-5512-4ba1-9587-17f97c8c778b 61 fields · synced May 18, 2026
  • EUDAMED 410d753f-b2cc-48bb-9418-6d818b8e5079 61 fields · synced May 18, 2026
  • EUDAMED 5a5de0ab-0233-4f28-870a-b1776ebab8a5 61 fields · synced May 18, 2026
  • EUDAMED 78461489-a2e4-4a51-994c-e7496bf1f3eb 61 fields · synced May 18, 2026
  • EUDAMED a45a1212-dbeb-4758-93a9-a4c5cd1a684e 61 fields · synced May 18, 2026
  • EUDAMED a3497669-1a3e-45fb-860a-8ba739b930d4 61 fields · synced May 18, 2026
  • EUDAMED 72f5439d-d3ae-45e7-88b4-75ad76c34e85 61 fields · synced May 19, 2026
  • EUDAMED dad7e81a-c7d3-43ee-81e6-3876544db6a1 61 fields · synced May 19, 2026
  • EUDAMED 2ffd65ac-cd7b-4808-ad51-b0abff838e14 61 fields · synced May 19, 2026
  • EUDAMED b46a6bdf-194e-4619-a9e9-3426be93df28 61 fields · synced May 19, 2026
  • EUDAMED 6a32e569-6e1f-4884-91ef-73bfe44d8f7d 61 fields · synced May 19, 2026