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Single Use Guidewire for endoscopic biliary procedures
EUDAMEDFDA UDIClass I (EU MDR)
Ref MD-A-GW2515
Identity
- Trade Name
- Single Use Guidewire for endoscopic biliary procedures EUDAMEDSingle Use Guidewire FDA UDI
- Generic Name
- Gastro-urological guidewire, single-use FDA UDI
- Device Name
- Single Use Guidewire for endoscopic biliary procedures EUDAMED
- Model / Reference
- MD-A-GW2515 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970401818273 EUDAMEDFDA UDI
- Basic UDI-DI
- 697040181GuidewireAZE EUDAMED
- FDA Product Code
- OCY FDA UDI
- EMDN Code
- G030499 ERCP AND SPHINCTEROTOMY DEVICES - OTHER EUDAMED
- GMDN Term
- Gastro-urological guidewire, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Single Use Guidewire for endoscopic biliary procedures by Zhejiang Chuangxiang Medical Technology Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA…
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697040181GuidewireAZE | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Zhejiang Chuangxiang Medical Technology Co., LTD.
- EUDAMED SRN
- CN-MF-000012417
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED a52d2480-cd32-4b26-bb09-7e65e5f95e8b 61 fields · synced Jul 23, 2026
- FDA UDI 744d777d-fe78-47e0-b6a1-2cda4ebf1541 32 fields · synced May 30, 2026