Identity
- Device Name
- URS. 040.00.1500 EUDAMED
- Model / Reference
- 9AMA-1085 EUDAMED9AMA-1021 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-9AMA-1085GF EUDAMEDD-9AMA-1021FM EUDAMED
- Basic UDI-DI
- B-9AMA-1085GF EUDAMEDB-9AMA-1021FM 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. 040.00.1500 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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- 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-1085GF | Class IIa | Active |
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Manufacturer
- Manufacturer
- Blazejewski MEDI-TECH GmbH
- EUDAMED SRN
- DE-MF-000005467
Sources (2)
- EUDAMED 0750e81f-47ae-4531-a813-e000720a8f61 61 fields · synced Sep 18, 2026
- EUDAMED 797af542-6a00-4811-86af-e3ae51e47c58 61 fields · synced May 18, 2026