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Guidewires
EUDAMEDClass IIa (EU MDR)
Ref 159025Model Hydrophilic coated 0.038＂x180cm (J)
Identity
- Device Name
- Guidewires EUDAMED
- Model / Reference
- Hydrophilic coated 0.038＂x180cm (J) EUDAMED159025 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971162813828 EUDAMED
- Basic UDI-DI
- B-06971162813828 EUDAMED
- EMDN Code
- C04030101 DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
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-06971162813828 | 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 (1)
- EUDAMED decb3f89-45db-4c4b-9c2b-ca6fe543f706 61 fields · synced Jun 19, 2026