Identity
- Device Name
- Nep. 90.074.15.2500a EUDAMED
- Model / Reference
- 9ABE-1021 EUDAMED9ABE-1010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-9ABE-1021BE EUDAMEDD-9ABE-1010B9 EUDAMED
- Basic UDI-DI
- B-9ABE-1021BE EUDAMEDB-9ABE-1010B9 EUDAMED
- EMDN Code
- Z12020705 NEPHROSCOPES 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
Nep. 90.074.15.2500a 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-9ABE-1021BE | Class IIa | Active |
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Manufacturer
- Manufacturer
- Blazejewski MEDI-TECH GmbH
- EUDAMED SRN
- DE-MF-000005467
Sources (2)
- EUDAMED 3a6261fa-6bb5-428a-8a7a-b466b8c7fdcf 61 fields · synced Aug 1, 2026
- EUDAMED 152f9992-a929-41ac-9a3f-d03ba030cca1 61 fields · synced May 19, 2026