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ChitoHeal Gel
EUDAMEDClass III (EU MDR)
Ref Chito-01 Rev.02Model ChitoHeal Gel 15 gr
Identity
- Trade Name
- ChitoHeal Gel EUDAMED
- Device Name
- ChitoHeal Gel EUDAMED
- Model / Reference
- ChitoHeal Gel 15 gr EUDAMEDChito-01 Rev.02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06260455502533 EUDAMED
- Basic UDI-DI
- B-06260455502533 EUDAMED
- EMDN Code
- M040499 DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - OTHER EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Negative-pressure wound therapy system foam dressing, non-antimicrobial
ChitoHeal Gel by ChitoTech (Keifiat Tolid Takapoo) — Class III — 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-06260455502533 | Class III | Active |
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Manufacturer
- Manufacturer
- ChitoTech (Keifiat Tolid Takapoo)
- EUDAMED SRN
- IR-MF-000043341
- Authorised Representative
- CERT3GLOBAL, UNIPESSOAL, LDA. PT-AR-000037982
Sources (1)
- EUDAMED 64d5eeae-c790-4dde-bc1e-e0ec58bf3168 61 fields · synced Jun 20, 2026