Identity
- Device Name
- URS. 040.00.2000 EUDAMED
- Model / Reference
- 9AMA-1104 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-9AMA-1104FS EUDAMED
- Basic UDI-DI
- B-9AMA-1104FS 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. 040.00.2000 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.
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- 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-1104FS | Class IIa | Active |
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Manufacturer
- Manufacturer
- Blazejewski MEDI-TECH GmbH
- EUDAMED SRN
- DE-MF-000005467
Sources (1)
- EUDAMED 3a1c1898-0bc5-46c4-b607-866d2f7aa4a6 61 fields · synced Jul 8, 2026