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Breathe Implant àWengen
EUDAMEDClass IIb (EU MDR)
Ref 6002012Ref 6002014Ref 6002015Ref 6002013Ref 6002016
Identity
- Trade Name
- Breathe Implant àWengen EUDAMED
- Device Name
- Breathe Implant àWengen EUDAMED
- Model / Reference
- 6002012 EUDAMED6002014 EUDAMED6002015 EUDAMED6002013 EUDAMED6002016 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14250368857126 EUDAMED14250368857140 EUDAMED14250368857157 EUDAMED14250368857133 EUDAMED14250368857164 EUDAMED
- Basic UDI-DI
- B-14250368857126 EUDAMEDB-14250368857140 EUDAMEDB-14250368857157 EUDAMEDB-14250368857133 EUDAMEDB-14250368857164 EUDAMED
- EMDN Code
- Q0399 ENT DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
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
Breathe Implant àWengen by Heinz Kurz GmbH — Class IIb — 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-14250368857126 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Heinz Kurz GmbH
- EUDAMED SRN
- DE-MF-000007959
Sources (5)
- EUDAMED 2a96c0f7-454a-4a85-af5a-3e2c6500f430 61 fields · synced Oct 6, 2026
- EUDAMED c185c20b-4a52-4ba0-8a8f-525de4261095 61 fields · synced May 17, 2026
- EUDAMED 24e0f980-73ec-42da-877a-6f5e607f4aaf 61 fields · synced May 18, 2026
- EUDAMED 81aedded-a173-48d5-ad84-0068565dcaf0 61 fields · synced May 18, 2026
- EUDAMED 20f4c7df-36ad-4829-8c98-5d35ec105407 61 fields · synced May 19, 2026