Identity
- Device Name
- Uro. 029.00.3020a EUDAMEDUro. 029.00.3020a 40k EUDAMED
- Model / Reference
- 9AGA-1005 EUDAMED9AGA-1041 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-9AGA-1005CH EUDAMEDD-9AGA-1041CM EUDAMED
- Basic UDI-DI
- B-9AGA-1005CH EUDAMEDB-9AGA-1041CM EUDAMED
- EMDN Code
- Z12020701 CYSTOSCOPES 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
Uro. 029.00.3020a by Blazejewski MEDI-TECH GmbH — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-9AGA-1005CH | Class IIa | Active |
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Manufacturer
- Manufacturer
- Blazejewski MEDI-TECH GmbH
- EUDAMED SRN
- DE-MF-000005467
Sources (2)
- EUDAMED 012f25c8-df64-4e33-8f70-763d6de14328 61 fields · synced Sep 18, 2026
- EUDAMED a26175ab-e967-4f3a-8546-0825a0d20ed9 61 fields · synced May 18, 2026