Identity
- Trade Name
- Sizer Breathe Implant àWengen EUDAMED
- Device Name
- Sizer Breathe Implant àWengen EUDAMED
- Model / Reference
- 8000253 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14250368862533 EUDAMED
- Basic UDI-DI
- B-14250368862533 EUDAMED
- EMDN Code
- L149099 ENT INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I 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
Sizer Breathe Implant àWengen 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-14250368862533 | Class I | Active |
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Manufacturer
- Manufacturer
- Heinz Kurz GmbH
- EUDAMED SRN
- DE-MF-000007959
Sources (1)
- EUDAMED ad5b5d2d-f7ee-4ec6-bb16-0d6d2d07b122 61 fields · synced Jun 19, 2026