Identity
- Trade Name
- Single-use Guidewire EUDAMEDFDA UDI
- Generic Name
- Gastro-urological guidewire, single-use FDA UDI
- Device Name
- Single-use Guidewire EUDAMEDThe product is composed of a core wire, outer sheath, soft head, and hydrophilic coating This product is intended to be inserted into the ureter, introduced into the ureteral catheter or other instruments under the direct vision of the endoscope during intracavitary urological surgery. FDA UDI
- Model / Reference
- GW-3515 EUDAMEDFDA UDI
- Description
- The product is composed of a core wire, outer sheath, soft head, and hydrophilic coating This product is intended to be inserted into the ureter, introduced into the ureteral catheter or other instruments under the direct vision of the endoscope during intracavitary urological surgery. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971381251630 EUDAMEDFDA UDI
- Basic UDI-DI
- 697138125019A8U EUDAMED
- Direct Marketing DI
- 06971381251630 EUDAMED
- FDA Product Code
- OCY FDA UDI
- EMDN Code
- U0601 UROLOGICAL GUIDEWIRES, HYDROPHILIC 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
- Belgium 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Single-use Guidewire by Scivita Medical Technology Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 697138125019A8U | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Scivita Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000010305
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 67410d17-7a65-46e2-bbfe-be382cb22390 61 fields · synced Jun 18, 2026
- FDA UDI 0b897bc6-6326-4fb8-bfb8-af1582839747 34 fields · synced May 30, 2026