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Single-use Extraction Baskets
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref EBT-08Model EBT-08、EBT-11、EBF-11、EBF-14
Identity
- Trade Name
- Single-use Extraction Baskets EUDAMEDFDA UDI
- Generic Name
- Biliary/urinary stone retrieval basket, single-use FDA UDI
- Device Name
- Single-use Extraction Baskets EUDAMEDThe product is composed of basket assembly, sheath assembly and handle assembly. This product is intended to capture, manipulate and remove stones and other foreign bodies during urinary diagnosis and treatment under endoscope. FDA UDI
- Model / Reference
- EBT-08、EBT-11、EBF-11、EBF-14 EUDAMEDEBT-08 EUDAMEDFDA UDI
- Description
- The product is composed of basket assembly, sheath assembly and handle assembly. This product is intended to capture, manipulate and remove stones and other foreign bodies during urinary diagnosis and treatment under endoscope. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971381251647 EUDAMEDFDA UDI
- Basic UDI-DI
- 697138125020A86 EUDAMED
- Direct Marketing DI
- 06971381251647 EUDAMED
- FDA Product Code
- FFL FDA UDI
- EMDN Code
- U090101 URINARY STONE RETRIEVAL BASKETS EUDAMED
- GMDN Term
- Biliary/urinary stone retrieval basket, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.4680 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 Extraction Baskets by Scivita Medical Technology 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 | 697138125020A86 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 3a9c39d5-7043-4867-88c8-0d535640b630 61 fields · synced Aug 1, 2026
- FDA UDI f1dd495f-720d-403d-ace2-29e175f11926 34 fields · synced May 29, 2026