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Guidewire
EUDAMEDClass IIa (EU MDR)
Ref 154009Model Straight tip, J tip, Angle tipRef 153016Ref 158009Model 0.035in×45cm(J)Ref 159032Ref 154010Ref 157031
Identity
- Device Name
- Guidewire EUDAMED
- Model / Reference
- Straight tip, J tip, Angle tip EUDAMED154009 EUDAMED153016 EUDAMED0.035in×45cm(J) EUDAMED158009 EUDAMED159032 EUDAMED154010 EUDAMED157031 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971162812586 EUDAMED06971162815068 EUDAMED06971162812746 EUDAMED06971162816300 EUDAMED06971162812593 EUDAMED06971162815891 EUDAMED
- Basic UDI-DI
- 697116281GW15GY EUDAMEDB-06971162812746 EUDAMED
- EMDN Code
- C04020102 PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye 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
Guidewire by Tianck Medical Co., Ltd. — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 697116281GW15GY | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697116281GW15GY | 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 (6)
- EUDAMED 30f93c2d-e4c6-4cf4-b50b-4868ebe1ff84 61 fields · synced Oct 6, 2026
- EUDAMED b9ce79e3-9b6b-4fbe-9404-be088a373538 61 fields · synced May 18, 2026
- EUDAMED 515badec-27a1-46db-9be8-59dd7b031465 61 fields · synced May 18, 2026
- EUDAMED bd710d1d-b333-41b9-b05e-234dfa9fee97 61 fields · synced May 18, 2026
- EUDAMED 99a0f3d9-42f4-4738-abdc-f0e2191e7ebb 61 fields · synced May 18, 2026
- EUDAMED dee832cd-c327-4c6b-b7e6-a04dbae0e213 61 fields · synced May 19, 2026