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Single-use Ureteral Access Sheath
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref UA-S1A00Model UA-S1800、UA-S1801、UA-S1A00、UA-S1A01、UA-S1B00、UA-S1B01、UA-S1C00、UA-S1C01、UA-S1D00、UA-S1D01
Identity
- Trade Name
- Single-use Ureteral Access Sheath EUDAMEDFDA UDI
- Generic Name
- Ureteral introduction sheath FDA UDI
- Device Name
- Single-use Ureteral Access Sheath EUDAMED
- Model / Reference
- UA-S1800、UA-S1801、UA-S1A00、UA-S1A01、UA-S1B00、UA-S1B01、UA-S1C00、UA-S1C01、UA-S1D00、UA-S1D01 EUDAMEDUA-S1A00 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06972197482249 EUDAMEDFDA UDI
- Basic UDI-DI
- 697219748UA01ND EUDAMED
- FDA Product Code
- FED FDA UDI
- EMDN Code
- U0399 DEVICES FOR URINARY TRACT DILATION - OTHER 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
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Single-use Ureteral Access Sheath by Hunan Vathin Medical Instrument Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K251599 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K240167 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697219748UA01ND | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hunan Vathin Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000002593
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (3)
- EUDAMED 836866f4-bea7-4bec-be3b-3ae0d3650f64 61 fields · synced Jul 31, 2026
- FDA UDI 0e4c6bb5-6c4f-4e95-91ca-9b0887ef039d 33 fields · synced May 30, 2026
- FDA 510(k) K251599 1 fields · synced May 18, 2026