Identity
- Device Name
- Uro. 018.00.2820 40k EUDAMED
- Model / Reference
- 9AGA-1028 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-9AGA-1028CV EUDAMED
- Basic UDI-DI
- B-9AGA-1028CV 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. 018.00.2820 40k 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-1028CV | Class IIa | Active |
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Manufacturer
- Manufacturer
- Blazejewski MEDI-TECH GmbH
- EUDAMED SRN
- DE-MF-000005467
Sources (1)
- EUDAMED 226d01f8-5bab-4709-9a88-3a0e0291f9df 61 fields · synced Jul 11, 2026