Identity
- Trade Name
- AC Sizer System Partial EUDAMED
- Device Name
- AC Sizer System Partial EUDAMED
- Model / Reference
- 8000540 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14250368865404 EUDAMED
- Basic UDI-DI
- B-14250368865404 EUDAMED
- EMDN Code
- P020180 OTOLOGIC PROSTHESES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
AC Sizer System Partial by Heinz Kurz GmbH — Class I — 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-14250368865404 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Heinz Kurz GmbH
- EUDAMED SRN
- DE-MF-000007959
Sources (1)
- EUDAMED bb85759b-fed5-43c6-915a-8a3d62189ee4 61 fields · synced Oct 6, 2026