Angiographic Guidewire
by Shenzhen Hainwise Medical Technology Co., Ltd. 58 variants
Ref SF.CA11.B39, SF.CA11.B84, SF.CA11.B64, SF.CA11.B23, SF.CA11.B27, SF.CA11.B85, SF.CA11.B69, SF.CA11.B123, SF.CA11.B57, SF.CA11.B99, SF.CA11.B07, SF.CA11.B113, SF.CA11.B45, SF.CA11.B87, SF.CA11.B55, SF.CA11.B82, SF.CA11.B94, SF.CA11.B46, SF.CA11.B103, SF.CA11.B12, SF.CA11.B81, SF.CA11.B102, SF.CA11.B14, SF.CA11.B108, SF.CA11.B50, SF.CA11.B52, SF.CA11.B11, SF.CA11.B18, SF.CA11.B104, SF.CA11.B70, SF.CA11.B80, SF.CA11.B32, SF.CA11.B53, SF.CA11.B05, SF.CA11.B127, SF.CA11.B76, SF.CA11.B100, SF.CA11.B15, SF.CA11.B62, SF.CA11.B47, SF.CA11.B66, SF.CA11.B83, SF.CA11.B20, SF.CA11.B74, SF.CA11.B92, SF.CA11.B78, SF.CA11.B49, SF.CA11.B73, SF.CA11.B30, SF.CA11.B16, SF.CA11.B56Model AW-18045NS
Active
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697605523CA0018R | Date4 Aug 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Angiographic Guidewire
- Model / Reference
- AW-18045NS, SF.CA11.B39, SF.CA11.B84, SF.CA11.B64, SF.CA11.B23, SF.CA11.B27, SF.CA11.B85, SF.CA11.B69, SF.CA11.B123, SF.CA11.B57, SF.CA11.B99, SF.CA11.B07, SF.CA11.B113, SF.CA11.B45, SF.CA11.B87, SF.CA11.B55, SF.CA11.B82, SF.CA11.B94, SF.CA11.B46, SF.CA11.B103, SF.CA11.B12, SF.CA11.B81, SF.CA11.B102, SF.CA11.B14, SF.CA11.B108, SF.CA11.B50, SF.CA11.B52, SF.CA11.B11, SF.CA11.B18, SF.CA11.B104, SF.CA11.B70, SF.CA11.B80, SF.CA11.B32, SF.CA11.B53, SF.CA11.B05, SF.CA11.B127, SF.CA11.B76, SF.CA11.B100, SF.CA11.B15, SF.CA11.B62, SF.CA11.B47, SF.CA11.B66, SF.CA11.B83, SF.CA11.B20, SF.CA11.B74, SF.CA11.B92, SF.CA11.B78, SF.CA11.B49, SF.CA11.B73, SF.CA11.B30, SF.CA11.B16, SF.CA11.B56
- Primary DI / UDI-DI
- 06976055233455, 06976055233905, 06976055233707, 06976055233295, 06976055233332, 06976055233912, 06976055233752, 06976055234612, 06976055233639, 06976055234377, 06976055233134, 06976055234513, 06976055233516, 06976055233936, 06976055233615, 06976055233882, 06976055234001, 06976055233523, 06976055234414, 06976055233189, 06976055233875, 06976055234407, 06976055233202, 06976055234469, 06976055233561, 06976055233585, 06976055233172, 06976055233240, 06976055234421, 06976055233769, 06976055233868, 06976055233387, 06976055233592, 06976055233110, 06976055234650, 06976055233820, 06976055234384, 06976055233219, 06976055233684, 06976055233530, 06976055233721, 06976055233899, 06976055233264, 06976055233806, 06976055233981, 06976055233844, 06976055233554, 06976055233790, 06976055233363, 06976055233226, 06976055233622
- Basic UDI-DI
- 697605523CA0018R
- Direct Marketing DI
- 069760552334550697605523390506976055233707069760552332950697605523333206976055233912069760552337520697605523461206976055233639069760552343770697605523313406976055234513069760552335160697605523393606976055233615069760552338820697605523400106976055233523069760552344140697605523318906976055233875069760552344070697605523320206976055234469069760552335610697605523358506976055233172069760552332400697605523442106976055233769069760552338680697605523338706976055233592069760552331100697605523465006976055233820069760552343840697605523321906976055233684069760552335300697605523372106976055233899069760552332640697605523380606976055233981069760552338440697605523355406976055233790069760552333630697605523322606976055233622
- EMDN Code
- C04020101 Peripheral vascular diagnostic guidewires, hydrophilic
- Device Class
- Class IIa
- EU market of registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- CN-MF-000037066
- Authorised representative
- Kingsmead Service B.V. NL-AR-000002066
Other devices from Shenzhen Hainwise Medical Technology Co., Ltd.
See all devices from Shenzhen Hainwise Medical Technology Co., Ltd. →
Properties
Other properties (12)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No