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HugeMed
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref Y-12-40Model Y-09-40, Y-09-50, Y-10-40, Y-10-50, Y-11-40, Y-11-50, Y-12-40, Y-12-50
Identity
- Trade Name
- HugeMed EUDAMEDSingle-use Ureteral Access Sheath FDA UDI
- Generic Name
- Ureteral introduction sheath FDA UDI
- Device Name
- Single-use Ureteral Access Sheath EUDAMED
- Model / Reference
- Y-09-40, Y-09-50, Y-10-40, Y-10-50, Y-11-40, Y-11-50, Y-12-40, Y-12-50 EUDAMEDY-12-40 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970462542698 EUDAMED06970462546801 FDA UDI
- Basic UDI-DI
- 69704625424078D EUDAMED
- 510(k) Number
- K250695 FDA UDI
- FDA Product Code
- FED FDA UDI
- EMDN Code
- U0280 URETERAL CATHETERS AND STENTS - ACCESSORIES EUDAMED
- GMDN Term
- Ureteral introduction sheath FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Germany 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
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
HugeMed by Shenzhen HugeMed Medical Technical Development Co., Ltd. — Class IIa — 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 | 69704625424078D | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- EUDAMED SRN
- CN-MF-000010895
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 72becd7f-d25a-4d92-8851-539e2f6e4d0f 61 fields · synced Aug 3, 2026
- FDA UDI 7816418a-31e8-4c03-8c03-2d4741cd70f6 33 fields · synced May 30, 2026