Identity
- Trade Name
- n.a, FDA UDI
- Generic Name
- Flexible video ureterorenoscope, single-use FDA UDI
- Device Name
- Flexible videoendoscopes, sterile, single use EUDAMEDVideo Uretero-Renoscope FLEX-XC1 FDA UDI
- Model / Reference
- 091279-06 EUDAMEDFDA UDI
- Description
- Video Uretero-Renoscope FLEX-XC1 FDA UDI
Identifiers
- Catalog Number
- 091279-06 FDA UDI
- Primary DI / UDI-DI
- 04048551428030 EUDAMEDFDA UDI
- Basic UDI-DI
- 4048551000063T4 EUDAMED
- Unit of Use DI
- 04048551480854 EUDAMED
- FDA Product Code
- FGB FDA UDI
- EMDN Code
- Z12020711 VIDEO CYSTOURETHROSCOPES EUDAMED
- GMDN Term
- Flexible video ureterorenoscope, single-use 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Flexible video ureterorenoscope, single-use
n.a, by Karl Storz GmbH & Co. KG — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Flexible video ureterorenoscope, single-use.
- Ambu® aScope™ 5 Uretero — Ambu A/S · Class II
- Single-Use Ureterorenoscope — Shenzhen HugeMed Medical Technical Development Co., Ltd. · Class II
- REDPINE — Guangzhou Red Pine Medical Instrument Co., Ltd. · Class II
- Single-Use Ureterorenoscope — Shenzhen HugeMed Medical Technical Development Co., Ltd. · Class II
- Ambu® aScope™ 5 Uretero — Ambu A/S · Class II
- REDPINE — Guangzhou Red Pine Medical Instrument Co., Ltd. · Class II
- REDPINE — Guangzhou Red Pine Medical Instrument Co., Ltd. · Class II
- REDPINE — Guangzhou Red Pine Medical Instrument Co., Ltd. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Karl Storz GmbH & Co. KG
Sources (2)
- FDA UDI c98a47f4-4ea3-4c9a-a70c-429af0413194 34 fields · synced Jul 16, 2026
- EUDAMED 6ae2330b-c371-47bb-8486-7c767d5284b8 61 fields · synced Jul 16, 2026