Identity
- Trade Name
- AC Sizer System Total EUDAMED
- Device Name
- AC Sizer System Total EUDAMED
- Model / Reference
- 8000550 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14250368865503 EUDAMED
- Basic UDI-DI
- B-14250368865503 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 Total 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-14250368865503 | Class I | Active |
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Manufacturer
- Manufacturer
- Heinz Kurz GmbH
- EUDAMED SRN
- DE-MF-000007959
Sources (1)
- EUDAMED dfe4e663-2acf-42e1-bcd2-2c53870d4982 61 fields · synced Jun 19, 2026