Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Rigid optical cystoscope FDA UDI
- Device Name
- Cystoscope 4 x 302 mm, 70° FDA UDI
- Model / Reference
- Cystoscopes EUDAMED41.0121a EUDAMEDFDA UDI
- Description
- Cystoscope 4 x 302 mm, 70° FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250480102848 EUDAMEDFDA UDI
- Basic UDI-DI
- 42504801CYSTOSCOPES7F EUDAMED
- Direct Marketing DI
- 04250480102848 EUDAMED
- FDA Product Code
- HIH FDA UDIFAJ FDA UDI
- EMDN Code
- Z12020701 CYSTOSCOPES EUDAMED
- GMDN Term
- Rigid optical cystoscope FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 884.1690 FDA UDI876.1500 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
Yes
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
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
41.0121a by SCHÖLLY FIBEROPTIC GmbH — 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 | 42504801CYSTOSCOPES7F | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Schölly Fiberoptic Gmbh
- EUDAMED SRN
- DE-MF-000005618
Sources (2)
- EUDAMED ce72a58f-f100-4e20-9854-1f89f5acbd0a 61 fields · synced Jul 9, 2026
- FDA UDI 2c4bcc81-d7ba-4ddb-b549-504572e03a8a 36 fields · synced May 29, 2026