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Balloon dilatation catheter

EUDAMED

Class IIa (EU MDR)

Ref 060080120HCModel 040/045/050/055/060/065/070/080/090/100/120-020/040/060/080/100-050/075/090/120-H/HCRef 045020120Model 040/045/050/055/060/065 /070/080/090/100/120-020/040/060/080/100-050/075/090/120Ref 080060120Ref 055040120HCRef 040060120HRef 055040050Ref 120080090HRef 065040090HCRef 060060090HRef 060080120Ref 050080120HCRef 045020050HCRef 070060075Ref 050060075HRef 045040075HCRef 065040090Ref 070020050Ref 090040075HRef 120080090Ref 045060120Ref 065020050HCRef 040020120HCRef 070080050Ref 055060090HCRef 040060090HRef 050020090HRef 040080050HCRef 100040075HRef 065020050HRef 050040050HCRef 080100090HRef 060060120Ref 100040090HRef 045060075Ref 065080090HRef 055020120HRef 065020120Ref 050080050Ref 100020090HRef 050020120HRef 050040120Ref 060100090HCRef 055080090HCRef 070060050HRef 060040075HRef 070100120Ref 065040120Ref 045020075Ref 040020075HCRef 045080050HCRef 080020090

by Cardiolink Science (Shenzhen) Medical Technology Development Co., Ltd.

Identity

Device Name
Balloon dilatation catheter EUDAMED
Model / Reference
040/045/050/055/060/065/070/080/090/100/120-020/040/060/080/100-050/075/090/120-H/HC EUDAMED
060080120HC EUDAMED
040/045/050/055/060/065 /070/080/090/100/120-020/040/060/080/100-050/075/090/120 EUDAMED
045020120 EUDAMED
080060120 EUDAMED
055040120HC EUDAMED
040060120H EUDAMED
055040050 EUDAMED
120080090H EUDAMED
065040090HC EUDAMED
060060090H EUDAMED
060080120 EUDAMED
050080120HC EUDAMED
045020050HC EUDAMED
070060075 EUDAMED
050060075H EUDAMED
045040075HC EUDAMED
065040090 EUDAMED
070020050 EUDAMED
090040075H EUDAMED
120080090 EUDAMED
045060120 EUDAMED
065020050HC EUDAMED
040020120HC EUDAMED
070080050 EUDAMED
055060090HC EUDAMED
040060090H EUDAMED
050020090H EUDAMED
040080050HC EUDAMED
100040075H EUDAMED
065020050H EUDAMED
050040050HC EUDAMED
080100090H EUDAMED
060060120 EUDAMED
100040090H EUDAMED
045060075 EUDAMED
065080090H EUDAMED
055020120H EUDAMED
065020120 EUDAMED
050080050 EUDAMED
100020090H EUDAMED
050020120H EUDAMED
050040120 EUDAMED
060100090HC EUDAMED
055080090HC EUDAMED
070060050H EUDAMED
060040075H EUDAMED
070100120 EUDAMED
065040120 EUDAMED
045020075 EUDAMED
040020075HC EUDAMED
045080050HC EUDAMED
080020090 EUDAMED

Identifiers

Primary DI / UDI-DI
06971741706725 EUDAMED
06971741701935 EUDAMED
06971741703151 EUDAMED
06971741706503 EUDAMED
06971741703830 EUDAMED
06971741702192 EUDAMED
06971741705698 EUDAMED
06971741706855 EUDAMED
06971741704585 EUDAMED
06971741702567 EUDAMED
06971741706329 EUDAMED
06971741705940 EUDAMED
06971741702857 EUDAMED
06971741704134 EUDAMED
06971741706008 EUDAMED
06971741702697 EUDAMED
06971741702789 EUDAMED
06971741705315 EUDAMED
06971741703618 EUDAMED
06971741701959 EUDAMED
06971741706749 EUDAMED
06971741705896 EUDAMED
06971741702819 EUDAMED
06971741706466 EUDAMED
06971741703786 EUDAMED
06971741704165 EUDAMED
06971741705773 EUDAMED
06971741705476 EUDAMED
06971741704660 EUDAMED
06971741706152 EUDAMED
06971741705209 EUDAMED
06971741702550 EUDAMED
06971741705513 EUDAMED
06971741701850 EUDAMED
06971741704790 EUDAMED
06971741704417 EUDAMED
06971741702734 EUDAMED
06971741702017 EUDAMED
06971741705506 EUDAMED
06971741704219 EUDAMED
06971741702147 EUDAMED
06971741706688 EUDAMED
06971741706473 EUDAMED
06971741704882 EUDAMED
06971741704523 EUDAMED
06971741702970 EUDAMED
06971741702741 EUDAMED
06971741701836 EUDAMED
06971741705797 EUDAMED
06971741705971 EUDAMED
06971741703083 EUDAMED
Basic UDI-DI
697174170BDC000188 EUDAMED
697174170BDC00028A EUDAMED
Direct Marketing DI
06971741706725 EUDAMED
06971741701935 EUDAMED
06971741703151 EUDAMED
06971741706503 EUDAMED
06971741703830 EUDAMED
06971741702192 EUDAMED
06971741705698 EUDAMED
06971741706855 EUDAMED
06971741704585 EUDAMED
06971741702567 EUDAMED
06971741706329 EUDAMED
06971741705940 EUDAMED
06971741702857 EUDAMED
06971741704134 EUDAMED
06971741706008 EUDAMED
06971741702697 EUDAMED
06971741702789 EUDAMED
06971741705315 EUDAMED
06971741703618 EUDAMED
06971741701959 EUDAMED
06971741706749 EUDAMED
06971741705896 EUDAMED
06971741702819 EUDAMED
06971741706466 EUDAMED
06971741703786 EUDAMED
06971741704165 EUDAMED
06971741705773 EUDAMED
06971741705476 EUDAMED
06971741704660 EUDAMED
06971741706152 EUDAMED
06971741705209 EUDAMED
06971741702550 EUDAMED
06971741705513 EUDAMED
06971741701850 EUDAMED
06971741704790 EUDAMED
06971741704417 EUDAMED
06971741702734 EUDAMED
06971741702017 EUDAMED
06971741705506 EUDAMED
06971741704219 EUDAMED
06971741702147 EUDAMED
06971741706688 EUDAMED
06971741706473 EUDAMED
06971741704882 EUDAMED
06971741704523 EUDAMED
06971741702970 EUDAMED
06971741702741 EUDAMED
06971741701836 EUDAMED
06971741705797 EUDAMED
06971741705971 EUDAMED
06971741703083 EUDAMED
EMDN Code
C010402020101 PTA BALLOON DILATATION CATHETERS EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Italy EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

Yes

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

Balloon dilatation catheter by Cardiolink Science (Shenzhen) Medical Technology Development Co., Ltd. — Class IIa — MDR — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Cardiolink Science (Shenzhen) Medical Technology Development Co., Ltd.
EUDAMED SRN
CN-MF-000037464
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (51)

  • EUDAMED 14caa480-a9d1-4479-b69c-90f0f76dbf67 61 fields · synced Oct 7, 2026
  • EUDAMED 1b16de4f-c58b-49f3-975e-24f4f614ea14 61 fields · synced May 11, 2026
  • EUDAMED 2db0b426-66ab-4067-9f6e-f5d69ed29c81 61 fields · synced May 11, 2026
  • EUDAMED 327d4865-ea33-4b3d-a78d-5cacafdcb7a1 61 fields · synced May 11, 2026
  • EUDAMED 43afac2d-0f66-435d-b83a-85be2c10b28d 61 fields · synced May 11, 2026
  • EUDAMED 553ddddc-0972-408c-a672-2febeee3f272 61 fields · synced May 11, 2026
  • EUDAMED aa9f867f-0b27-48be-b810-a525c74675e2 61 fields · synced May 11, 2026
  • EUDAMED abf0624c-8d34-46a8-bcd2-6b4fc7d5cb4b 61 fields · synced May 11, 2026
  • EUDAMED cf1df986-bae5-4992-9f80-e23753ef8de6 61 fields · synced May 11, 2026
  • EUDAMED dec41beb-dde5-4368-828f-fdeb74413084 61 fields · synced May 11, 2026
  • EUDAMED e48dd6a4-d01c-414c-a87d-b711f4d6c417 61 fields · synced May 11, 2026
  • EUDAMED 10d6c730-ca07-49ee-af88-505cd48f5435 61 fields · synced May 11, 2026
  • EUDAMED 10c2c570-dbb9-4986-95f6-84de250ffec6 61 fields · synced May 11, 2026
  • EUDAMED 12cf4386-62d6-4780-9f97-e0c35d38024f 61 fields · synced May 11, 2026
  • EUDAMED 15606022-a8b5-4429-b6e7-2fcece7854b6 61 fields · synced May 11, 2026
  • EUDAMED bce572da-b9e6-4738-912c-c1ac35e0e2c2 61 fields · synced May 16, 2026
  • EUDAMED b2e0953c-2af2-4225-80b6-f1ca5acc0f5c 61 fields · synced May 16, 2026
  • EUDAMED 9a7fa878-850d-4860-acc8-c3afae18d041 61 fields · synced May 16, 2026
  • EUDAMED 2df75456-27fb-4a95-94ef-d0f09d86d37d 61 fields · synced May 16, 2026
  • EUDAMED 0938aeac-10c1-4c8e-a307-b48ee306c40a 61 fields · synced May 16, 2026
  • EUDAMED 92dbd437-52e8-464e-a8db-c56c48ddf0f9 61 fields · synced May 16, 2026
  • EUDAMED 033f083a-d976-486f-b32c-0e896d4d0609 61 fields · synced May 16, 2026
  • EUDAMED bc2bce4b-3a55-4e61-9c29-27d9fef5fa8a 61 fields · synced May 16, 2026
  • EUDAMED 73cbe07d-dbc3-4382-bdc4-c1bad7accdc3 61 fields · synced May 16, 2026
  • EUDAMED 8335e56f-3161-4b4f-9b5f-dac13f037b01 61 fields · synced May 16, 2026
  • EUDAMED d0df3e8c-86f3-4b4e-8368-2aa04d007f41 61 fields · synced May 16, 2026
  • EUDAMED 8ff4e89c-9a73-4c6d-9872-9a23a31639ed 61 fields · synced May 16, 2026
  • EUDAMED 864ca7fd-6501-42f3-b008-401321eee3bf 61 fields · synced May 16, 2026
  • EUDAMED d56a3790-0bcf-4306-9c1b-14f314d08237 61 fields · synced May 16, 2026
  • EUDAMED 2e480fe5-c361-44e5-9d84-124f5aba63d5 61 fields · synced May 16, 2026
  • EUDAMED 38ede872-a54f-4ad4-bf53-09a2673a2ae4 61 fields · synced May 16, 2026
  • EUDAMED 40badfeb-5eee-4f98-8fa3-e717052e8373 61 fields · synced May 16, 2026
  • EUDAMED 9ff8a04f-d419-44b1-87fd-3ca793bbb76f 61 fields · synced May 16, 2026
  • EUDAMED 742afba4-cd86-43e4-aca9-e92a6c9e2fdb 61 fields · synced May 16, 2026
  • EUDAMED abec1121-6eaf-4d21-911d-145718ad36a9 61 fields · synced May 16, 2026
  • EUDAMED bd54ce6a-9286-4cd4-9cbd-3fee5c330ea1 61 fields · synced May 16, 2026
  • EUDAMED 21cdb602-9c6c-4ba9-ac9e-0f86162e3683 61 fields · synced May 16, 2026
  • EUDAMED 8518cf3d-6c03-45cf-a10e-e7646a3b5d22 61 fields · synced May 16, 2026
  • EUDAMED e67e163f-9b3a-4855-9d8c-93088f28bc89 61 fields · synced May 16, 2026
  • EUDAMED e0a0f7a6-16ca-44fe-a8c9-b5aa72df2cba 61 fields · synced May 16, 2026
  • EUDAMED dc472d10-9494-4020-8ec9-e45c9a892642 61 fields · synced May 16, 2026
  • EUDAMED 10ab8d11-22c6-425c-a094-fadf5ea8a916 61 fields · synced May 16, 2026
  • EUDAMED cfc163f4-d7dd-4b18-b4bc-35b4b6afc8fc 61 fields · synced May 16, 2026
  • EUDAMED 8580eec8-f477-4abb-9893-79c9bc57b120 61 fields · synced May 16, 2026
  • EUDAMED 6a8268be-ec24-483d-ab65-aa56694de8f8 61 fields · synced May 16, 2026
  • EUDAMED db4082e5-51f9-4c85-be8e-70b8441d95d5 61 fields · synced May 16, 2026
  • EUDAMED 72dce17a-e2dd-46e9-9371-9029b8569eb1 61 fields · synced May 16, 2026
  • EUDAMED 4f156022-f48c-4ff3-8076-3ca3d9f3493c 61 fields · synced May 16, 2026
  • EUDAMED 374c6fc4-57c4-442b-886e-de0544f05d19 61 fields · synced May 16, 2026
  • EUDAMED 759dfc34-6603-4253-a8ee-981b57539663 61 fields · synced May 16, 2026
  • EUDAMED 63a54089-961c-4f1e-b493-944bb90ba85b 61 fields · synced May 16, 2026