Identity
- Trade Name
- HD-VIEW FDA UDI
- Generic Name
- Flexible video cystoscope, reusable FDA UDI
- Device Name
- Flexible videoendoscopes EUDAMEDFlexible Video Cystoscope HD-VIEW FDA UDI
- Model / Reference
- 11272VH EUDAMEDFDA UDI
- Description
- Flexible Video Cystoscope HD-VIEW FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04048551423226 EUDAMEDFDA UDI
- Basic UDI-DI
- 4048551000177TL EUDAMED
- FDA Product Code
- FAJ FDA UDI
- EMDN Code
- Z12020702 CYSTOURETHROSCOPES EUDAMED
- GMDN Term
- Flexible video cystoscope, 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 cystoscope, reusable
Hd-View 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 cystoscope, reusable.
- Flexible Video Cystoscope (NTSC) — COGENTIX MEDICAL, INC. · Class II
- Flexible Video Cystoscope (NTSC) Intuitive — COGENTIX MEDICAL, INC. · Class II
- LUMINELLE DTx Hysteroscopy System — Uvision360, Inc. · Class II
- MAMBA VISION — Richard Wolf GmbH · Class II
- DirectVision — Percuvision, LLC · Class II
- VIDEO CYTOSCOPE — PENTAX of America, Inc. · Class II
- Luminelle DTx Control Hub — Uvision360, Inc. · Class II
- MAMBA VISION — Richard Wolf GmbH · 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 21a897c4-19e7-465b-9764-49b304d5a130 33 fields · synced Jul 20, 2026
- EUDAMED b21e499b-4135-4ea6-a16b-975f79812054 61 fields · synced Jul 20, 2026