Identity
- Trade Name
- Flex-X / IMAGE 1 S FDA UDI
- Generic Name
- Flexible video ureterorenoscope, reusable FDA UDI
- Device Name
- Flexible videoendoscopes, suction/irrigation, natural body orifices EUDAMEDVideo Uretero-Renoscope FLEX-XC FDA UDI
- Model / Reference
- 11278VS EUDAMEDFDA UDI
- Description
- Video Uretero-Renoscope FLEX-XC FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04048551344408 EUDAMEDFDA UDI
- Basic UDI-DI
- 4048551005441UH EUDAMED
- FDA Product Code
- FGB FDA UDI
- EMDN Code
- Z12020799 GENITOURINARY ENDOSCOPY INSTRUMENTS – OTHER EUDAMED
- GMDN Term
- Flexible video ureterorenoscope, reusable 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
No
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Category: Flexible video ureterorenoscope, reusable
Flex-X / IMAGE 1 S 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, reusable.
- COBRA VISION — Richard Wolf GmbH · Class II
- URETERO-RENO VIDEOSCOPE — Olympus Medical Systems Corporation · Class II
- BOA VISION — Richard Wolf GmbH · Class II
- URETERO-RENO VIDEOSCOPE — Olympus Medical Systems Corporation · Class II
- BOA VISION — Richard Wolf GmbH · Class II
- URETERO-RENO VIDEOSCOPE — Olympus Medical Systems Corporation · Class II
- BOA VISION — Richard Wolf GmbH · Class II
- URETERO-RENO VIDEOSCOPE — Olympus Medical Systems Corporation · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Karl Storz GmbH & Co. KG
Sources (2)
- FDA UDI b6294189-463f-4188-8f53-2cb854df494b 33 fields · synced Jun 19, 2026
- EUDAMED f81e6a8e-ecaf-46b3-9598-98a0a1b8abe6 61 fields · synced Jun 19, 2026