Identity
- Trade Name
- Maxipore EUDAMED
- Device Name
- Maxipore Transparent PU Film Dressing EUDAMED
- Model / Reference
- S628 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08699664200349 EUDAMED
- Basic UDI-DI
- B-08699664200349 EUDAMED
- EMDN Code
- M04040601 POLYURETHANE DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye 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
Category: Negative-pressure wound therapy system foam dressing, non-antimicrobial
Maxipore by Seyi̇tler Ki̇mya Sanayi̇ A.ş. — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Negative-pressure wound therapy system foam dressing, non-antimicrobial.
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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-08699664200349 | Class I | Active |
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Manufacturer
- Manufacturer
- Seyi̇tler Ki̇mya Sanayi̇ A.ş.
- EUDAMED SRN
- TR-MF-000019722
Sources (1)
- EUDAMED 21e8fac7-d398-4c48-81ca-ad8d5d260468 61 fields · synced Jun 18, 2026