Guidewires

EUDAMED

Class IIa (EU MDR)

Ref 155037Model PTFE coated 0.025＂x150cm(J)Ref 159051Model Nitinol 0.038＂x150cm(J)Ref 159037Model PTFE coated 0.038＂x150cm(J)Ref 156018Model Zebra 0.028＂x150cm (S)Ref 159020Model Zebra 0.038＂x260cm (S)Ref 157021Model Zebra 0.032＂x450cm (J)Ref 159039Model PTFE coated 0.038＂x180cm(J)Ref 152030Model Hydrophilic tip PTCA 0.014＂x190cm (S)Ref 159045Model Nitinol 0.038＂x60cm(J)Ref 157044Model Nitinol 0.032＂x45cm(S)Ref 152031Ref 157019Model Zebra 0.032＂x260cm (J)Ref 157037Model PTFE coated 0.032＂x150cm(J)Ref 156020Model Zebra 0.028＂x260cm (S)Ref 155023Model Hydrophilic coated 0.025＂x150cm (J)Ref 158041Model PTFE coated 0.035＂x260cm(J)Ref 158037Model PTFE coated 0.035＂x150cm(J)Ref 155019Model Zebra 0.025＂x260cm (J)Ref 157048Model Zebra 0.032＂x180cm (S)Ref 152025Model PTCA 0.014＂x190cm (J)Ref 157017Model Zebra 0.032＂x150cm (J)Ref 159044Model Nitinol 0.038＂x45cm(S)Ref 158044Model Nitinol 0.035＂x45cm(S)Ref 155024Model Hydrophilic coated 0.025＂x150cm (S)Ref 159038Model PTFE coated 0.038＂x150cm(S)Ref 158056Model Hydrophilic Tip Zebra 0.035＂x260cm (S)Ref 155026Model Hydrophilic coated 0.025＂x180cm (S)Ref 158062Model Nitinol 0.035＂x150cm(J)Ref 152032Ref 152051Model PTCA 0.014＂x300cm (S)Ref 158023Model Hydrophilic coated 0.035＂x150cm (J)Ref 157020Model Zebra 0.032＂x260cm (S)Ref 157046Model Nitinol 0.032＂x60cm(S)Ref 154027Model Radial artery 0.021＂x45cmRef 159024Model Hydrophilic coated 0.038＂x150cm (S)Ref 155047Model Radial artery 0.025＂x45cmRef 159052Model Nitinol 0.038＂x150cm(S)Ref 159021Model Zebra 0.038＂x450cm (J)Ref 156022Model Zebra 0.028＂x450cm (S)Ref 156026Model Hydrophilic coated 0.028＂x180cm (S)Ref 158043Model Nitinol 0.035＂x45cm(J)Ref 159042Model PTFE coated 0.038＂x260cm(S)Ref 158050Model Zebra 0.035＂x180cm (S)Ref 152059Model Hydrophilic tip PTCA 0.014＂x190cm (J)Ref 157042Model PTFE coated 0.032＂x260cm(S)Ref 159048Model Zebra 0.038＂x180cm (S)Ref 152048Model PTCA 0.014＂x300cm (J)Ref 158045Model Nitinol 0.035＂x60cm(J)Ref 152037Model PTCA 0.014＂x190cm (S)Ref 158021Model Zebra 0.035＂x450cm (J)Ref 155021Model Zebra 0.025＂x450cm (S)

by Tianck Medical Co., Ltd.

Identity

Device Name: Guidewires EUDAMED
Model / Reference: PTFE coated 0.025＂x150cm(J) EUDAMED
155037 EUDAMED
Nitinol 0.038＂x150cm(J) EUDAMED
159051 EUDAMED
PTFE coated 0.038＂x150cm(J) EUDAMED
159037 EUDAMED
Zebra 0.028＂x150cm (S) EUDAMED
156018 EUDAMED
Zebra 0.038＂x260cm (S) EUDAMED
159020 EUDAMED
Zebra 0.032＂x450cm (J) EUDAMED
157021 EUDAMED
PTFE coated 0.038＂x180cm(J) EUDAMED
159039 EUDAMED
Hydrophilic tip PTCA 0.014＂x190cm (S) EUDAMED
152030 EUDAMED
Nitinol 0.038＂x60cm(J) EUDAMED
159045 EUDAMED
Nitinol 0.032＂x45cm(S) EUDAMED
157044 EUDAMED
152031 EUDAMED
Zebra 0.032＂x260cm (J) EUDAMED
157019 EUDAMED
PTFE coated 0.032＂x150cm(J) EUDAMED
157037 EUDAMED
Zebra 0.028＂x260cm (S) EUDAMED
156020 EUDAMED
Hydrophilic coated 0.025＂x150cm (J) EUDAMED
155023 EUDAMED
PTFE coated 0.035＂x260cm(J) EUDAMED
158041 EUDAMED
PTFE coated 0.035＂x150cm(J) EUDAMED
158037 EUDAMED
Zebra 0.025＂x260cm (J) EUDAMED
155019 EUDAMED
Zebra 0.032＂x180cm (S) EUDAMED
157048 EUDAMED
PTCA 0.014＂x190cm (J) EUDAMED
152025 EUDAMED
Zebra 0.032＂x150cm (J) EUDAMED
157017 EUDAMED
Nitinol 0.038＂x45cm(S) EUDAMED
159044 EUDAMED
Nitinol 0.035＂x45cm(S) EUDAMED
158044 EUDAMED
Hydrophilic coated 0.025＂x150cm (S) EUDAMED
155024 EUDAMED
PTFE coated 0.038＂x150cm(S) EUDAMED
159038 EUDAMED
Hydrophilic Tip Zebra 0.035＂x260cm (S) EUDAMED
158056 EUDAMED
Hydrophilic coated 0.025＂x180cm (S) EUDAMED
155026 EUDAMED
Nitinol 0.035＂x150cm(J) EUDAMED
158062 EUDAMED
152032 EUDAMED
PTCA 0.014＂x300cm (S) EUDAMED
152051 EUDAMED
Hydrophilic coated 0.035＂x150cm (J) EUDAMED
158023 EUDAMED
Zebra 0.032＂x260cm (S) EUDAMED
157020 EUDAMED
Nitinol 0.032＂x60cm(S) EUDAMED
157046 EUDAMED
Radial artery 0.021＂x45cm EUDAMED
154027 EUDAMED
Hydrophilic coated 0.038＂x150cm (S) EUDAMED
159024 EUDAMED
Radial artery 0.025＂x45cm EUDAMED
155047 EUDAMED
Nitinol 0.038＂x150cm(S) EUDAMED
159052 EUDAMED
Zebra 0.038＂x450cm (J) EUDAMED
159021 EUDAMED
Zebra 0.028＂x450cm (S) EUDAMED
156022 EUDAMED
Hydrophilic coated 0.028＂x180cm (S) EUDAMED
156026 EUDAMED
Nitinol 0.035＂x45cm(J) EUDAMED
158043 EUDAMED
PTFE coated 0.038＂x260cm(S) EUDAMED
159042 EUDAMED
Zebra 0.035＂x180cm (S) EUDAMED
158050 EUDAMED
Hydrophilic tip PTCA 0.014＂x190cm (J) EUDAMED
152059 EUDAMED
PTFE coated 0.032＂x260cm(S) EUDAMED
157042 EUDAMED
Zebra 0.038＂x180cm (S) EUDAMED
159048 EUDAMED
PTCA 0.014＂x300cm (J) EUDAMED
152048 EUDAMED
Nitinol 0.035＂x60cm(J) EUDAMED
158045 EUDAMED
PTCA 0.014＂x190cm (S) EUDAMED
152037 EUDAMED
Zebra 0.035＂x450cm (J) EUDAMED
158021 EUDAMED
Zebra 0.025＂x450cm (S) EUDAMED
155021 EUDAMED

Identifiers

Primary DI / UDI-DI: 06971162813033 EUDAMED
06971162818281 EUDAMED
06971162813224 EUDAMED
06971162813354 EUDAMED
06971162813613 EUDAMED
06971162813460 EUDAMED
06971162813248 EUDAMED
06971162817864 EUDAMED
06971162813002 EUDAMED
06971162812913 EUDAMED
06971162817871 EUDAMED
06971162813446 EUDAMED
06971162813095 EUDAMED
06971162813378 EUDAMED
06971162813644 EUDAMED
06971162813200 EUDAMED
06971162813163 EUDAMED
06971162813309 EUDAMED
06971162813439 EUDAMED
06971162813880 EUDAMED
06971162813408 EUDAMED
06971162812999 EUDAMED
06971162812951 EUDAMED
06971162813651 EUDAMED
06971162813231 EUDAMED
06971162817734 EUDAMED
06971162813675 EUDAMED
06971162818250 EUDAMED
06971162817765 EUDAMED
06971162818885 EUDAMED
06971162813767 EUDAMED
06971162813453 EUDAMED
06971162812937 EUDAMED
06971162813842 EUDAMED
06971162813811 EUDAMED
06971162813859 EUDAMED
06971162818298 EUDAMED
06971162813620 EUDAMED
06971162813392 EUDAMED
06971162813712 EUDAMED
06971162812944 EUDAMED
06971162813279 EUDAMED
06971162813514 EUDAMED
06971162819035 EUDAMED
06971162813156 EUDAMED
06971162813590 EUDAMED
06971162818854 EUDAMED
06971162812968 EUDAMED
06971162818960 EUDAMED
06971162813545 EUDAMED
06971162813330 EUDAMED
Basic UDI-DI: B-06971162813033 EUDAMED
B-06971162818281 EUDAMED
B-06971162813224 EUDAMED
B-06971162813354 EUDAMED
B-06971162813613 EUDAMED
B-06971162813460 EUDAMED
B-06971162813248 EUDAMED
B-06971162817864 EUDAMED
B-06971162813002 EUDAMED
B-06971162812913 EUDAMED
B-06971162817871 EUDAMED
B-06971162813446 EUDAMED
B-06971162813095 EUDAMED
B-06971162813378 EUDAMED
B-06971162813644 EUDAMED
B-06971162813200 EUDAMED
B-06971162813163 EUDAMED
B-06971162813309 EUDAMED
B-06971162813439 EUDAMED
B-06971162813880 EUDAMED
B-06971162813408 EUDAMED
B-06971162812999 EUDAMED
B-06971162812951 EUDAMED
B-06971162813651 EUDAMED
B-06971162813231 EUDAMED
B-06971162817734 EUDAMED
B-06971162813675 EUDAMED
B-06971162818250 EUDAMED
B-06971162817765 EUDAMED
B-06971162818885 EUDAMED
B-06971162813767 EUDAMED
B-06971162813453 EUDAMED
B-06971162812937 EUDAMED
B-06971162813842 EUDAMED
B-06971162813811 EUDAMED
B-06971162813859 EUDAMED
B-06971162818298 EUDAMED
B-06971162813620 EUDAMED
B-06971162813392 EUDAMED
B-06971162813712 EUDAMED
B-06971162812944 EUDAMED
B-06971162813279 EUDAMED
B-06971162813514 EUDAMED
B-06971162819035 EUDAMED
B-06971162813156 EUDAMED
B-06971162813590 EUDAMED
B-06971162818854 EUDAMED
B-06971162812968 EUDAMED
B-06971162818960 EUDAMED
B-06971162813545 EUDAMED
B-06971162813330 EUDAMED
EMDN Code: C04030102 DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, NON-HYDROPHILIC EUDAMED
C04020102 PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC EUDAMED
C04010101 CORONARY ARTERY DIAGNOSTIC GUIDEWIRES, HYDROPHILIC EUDAMED
C04030101 DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC EUDAMED
C04010102 CORONARY ARTERY DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC EUDAMED

Classification

Device Class: Class IIa EUDAMED
Market of Registration: Netherlands EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

EUDAMED

Reusable

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Guidewires by Tianck Medical Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS

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-06971162813033	Class IIa	Active

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Manufacturer

Manufacturer: Tianck Medical Co., Ltd.
EUDAMED SRN: CN-MF-000007451
Authorised Representative: Lotus NL B.V. NL-AR-000000121

Sources (51)

EUDAMED f7d7bb58-1b7d-46e3-bbea-0c7b0ac738d8 61 fields · synced Oct 5, 2026
EUDAMED 1584c660-2633-4b2e-a1a8-64b459bed503 61 fields · synced May 11, 2026
EUDAMED adf8b3c8-6118-474a-848d-3e470647c4a2 61 fields · synced May 16, 2026
EUDAMED 0edfc7c3-cc95-4dd3-80b9-a267faec967d 61 fields · synced May 16, 2026
EUDAMED 307ceb3e-d304-4f9e-857d-5aead4ec5b47 61 fields · synced May 16, 2026
EUDAMED f6e3f020-bd12-4d2e-b6f7-d83ad39519f2 61 fields · synced May 16, 2026
EUDAMED ed88dd49-735e-4359-9ef7-ef7ad5128b7b 61 fields · synced May 16, 2026
EUDAMED 355ac2a6-0d6f-4d4d-b9bc-db93df4f786a 61 fields · synced May 16, 2026
EUDAMED 2a2bda22-ed96-4804-b0db-88ef07eec16a 61 fields · synced May 16, 2026
EUDAMED e6256c85-eecf-4a38-a16d-5f44048d8b67 61 fields · synced May 16, 2026
EUDAMED 72cd64f3-f7e0-4ef1-8f96-13f68fc4675e 61 fields · synced May 16, 2026
EUDAMED 518e8c06-cdc9-47f7-8456-ef2299c0dfc2 61 fields · synced May 16, 2026
EUDAMED 9075af84-c554-4911-b374-2eada8165cdc 61 fields · synced May 16, 2026
EUDAMED 515e9cda-d5b8-45ee-8a13-965e28b8dd74 61 fields · synced May 16, 2026
EUDAMED 9d207dcd-7457-4595-8dd9-7b8c705e6679 61 fields · synced May 16, 2026
EUDAMED 5498914b-4a37-45c1-9edd-c73ac9143216 61 fields · synced May 16, 2026
EUDAMED 64b95f6c-95ef-4ad5-ba81-dabba7ce8fcf 61 fields · synced May 16, 2026
EUDAMED b89c4fed-d970-4a53-b41b-c4dcace10a1a 61 fields · synced May 16, 2026
EUDAMED 9e51947e-b846-43ca-b6e5-f72547f08c6c 61 fields · synced May 16, 2026
EUDAMED 024ae417-8473-4a9b-a1b7-1b164b386e21 61 fields · synced May 16, 2026
EUDAMED f5684442-aaa0-49f1-80a0-c225f26c996c 61 fields · synced May 16, 2026
EUDAMED 087a4e62-cd6c-4eb8-8139-1197d2c5bd5b 61 fields · synced May 16, 2026
EUDAMED c79f7fd1-0b5d-4cd8-b096-2472092bf1e4 61 fields · synced May 17, 2026
EUDAMED 898d2d31-b990-4261-a049-9f7bd6364576 61 fields · synced May 17, 2026
EUDAMED ce6794fd-aa2a-4fc2-9c3c-a19eee5aee22 61 fields · synced May 17, 2026
EUDAMED 3bb5c9af-2f7a-4893-bd89-598b957a8c88 61 fields · synced May 17, 2026
EUDAMED f780e9bb-e587-43e8-beff-99fe85853676 61 fields · synced May 17, 2026
EUDAMED 360ba3e5-5ec3-48a2-804f-4b412366c6c2 61 fields · synced May 17, 2026
EUDAMED 70e372f9-5065-4e23-a41c-bbd9d90553ff 61 fields · synced May 17, 2026
EUDAMED 61ba2d37-39cd-4cce-bae4-bc6ba2f6a5f5 61 fields · synced May 17, 2026
EUDAMED df6212f9-4905-4086-989d-48a96e47da79 61 fields · synced May 17, 2026
EUDAMED 4d691185-eee3-48fd-9a62-b92ec18c4c69 61 fields · synced May 17, 2026
EUDAMED 782a5a62-4e29-41ec-960c-c69363b1578c 61 fields · synced May 17, 2026
EUDAMED aa928d6a-5fc6-44fb-be9d-b5a4e156d33b 61 fields · synced May 17, 2026
EUDAMED 4427cd10-ccdf-4a26-b354-32b81d07d6b4 61 fields · synced May 17, 2026
EUDAMED 15bafbdc-c4b6-4cbd-9bc7-5be6423957b3 61 fields · synced May 17, 2026
EUDAMED 7dda68c7-517c-453d-a667-bd75a94e9328 61 fields · synced May 17, 2026
EUDAMED f6af31db-469a-423e-877f-51d0cf66e3ca 61 fields · synced May 17, 2026
EUDAMED ed9ca412-0af1-4311-b51b-bdfba6378615 61 fields · synced May 17, 2026
EUDAMED a3913c7d-ae73-402c-b7ef-926c3eb43180 61 fields · synced May 17, 2026
EUDAMED a62d80d9-539c-4e28-9d85-215e36397831 61 fields · synced May 17, 2026
EUDAMED 3d51da9f-2eab-4a1e-8c0a-96d7eae009f2 61 fields · synced May 17, 2026
EUDAMED b869ddd2-36ca-4570-bf5a-d25dbc97519a 61 fields · synced May 17, 2026
EUDAMED bdd22a8f-c476-4840-9860-43275aaec669 61 fields · synced May 17, 2026
EUDAMED 7356877d-d014-444e-bf91-e7cf85ae0949 61 fields · synced May 17, 2026
EUDAMED 444e6652-655e-4be5-93df-add47730aac3 61 fields · synced May 17, 2026
EUDAMED b9de967c-e2a9-4f9c-a983-5c4aba535098 61 fields · synced May 17, 2026
EUDAMED 8a2b594c-fa8d-4fbd-a919-f90bf5b6ac05 61 fields · synced May 17, 2026
EUDAMED 9b434c15-cac8-435b-ae57-bc8a249e01ec 61 fields · synced May 17, 2026
EUDAMED ab122e56-8cc3-4073-8901-ca694ff8ba5a 61 fields · synced May 17, 2026
EUDAMED 35c7e56f-89ec-4f39-9164-445cf47b94c8 61 fields · synced May 17, 2026