← Back to catalogue
URS. 034.00.4250a
EUDAMEDClass IIa (EU MDR)
Ref 9AMA-1075Ref 9AMA-1074Ref 9AMA-1098
Identity
- Device Name
- URS. 034.00.4250a EUDAMED
- Model / Reference
- 9AMA-1075 EUDAMED9AMA-1074 EUDAMED9AMA-1098 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-9AMA-1075GC EUDAMEDD-9AMA-1074GA EUDAMEDD-9AMA-1098GQ EUDAMED
- Basic UDI-DI
- B-9AMA-1075GC EUDAMEDB-9AMA-1074GA EUDAMEDB-9AMA-1098GQ EUDAMED
- EMDN Code
- Z12020713 URETERORENOSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Flexible video ureteroscope, single-use
URS. 034.00.4250a by Blazejewski MEDI-TECH GmbH — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Flexible video ureteroscope, single-use.
- Single-use Flexible Uretero-Renoscope — Zhuhai Vision Medical Technology Co., Ltd · Class IIa
- Ureterorenoscope — Innoview GmbH · Class IIa
- WiScope® — OTU MEDICAL INC. · Class II
- CoralView® — MacroLux Medical Technology Co., Ltd. · Class II
- LithoVue — Boston Scientific · Class II
- Single-use Digital Flexible Ureterorenoscopes — NINGBO XINWELL MEDICAL TECHNOLOGY CO., LTD. · Class IIa
- Flexible Ureterorenoscopes — Shanghai Anqing Medical Instrument Co., Ltd · Class IIa
- WiScope® — OTU MEDICAL INC. · Class II
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-9AMA-1075GC | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Blazejewski MEDI-TECH GmbH
- EUDAMED SRN
- DE-MF-000005467
Sources (3)
- EUDAMED 62545495-628a-4ef9-acca-87b910811ecf 61 fields · synced Aug 4, 2026
- EUDAMED f32d8fd0-afee-477a-a77b-45cba749cd8f 61 fields · synced May 16, 2026
- EUDAMED 09b04c99-0afa-4c61-bd77-3a21d76d7da6 61 fields · synced May 18, 2026