Identity
- Device Name
- Tissue expander EUDAMED
- Model / Reference
- Tissue expander EUDAMED50680-700 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04046745030656 EUDAMED
- Basic UDI-DI
- B-04046745030656 EUDAMED
- EMDN Code
- P900104 RECTANGULAR TISSUE EXPANDERS 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Skin-port tissue expander
Tissue expander by POLYTECH Health & Aesthetics GmbH — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-04046745030656 | Class IIb | Active |
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Manufacturer
- Manufacturer
- POLYTECH Health & Aesthetics GmbH
- EUDAMED SRN
- DE-MF-000018836
Sources (1)
- EUDAMED 8dd4b45b-5608-49cc-b4f8-7993599aba74 61 fields · synced Jun 19, 2026