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ChitoHeal Gel
EUDAMEDClass III (EU MDR)
Ref chito-01 Rev.02Model ChitoHeal Gel 30 gRef Chito-01 Rev.02Model ChitoHeal Gel 60 gr
Identity
- Trade Name
- ChitoHeal Gel EUDAMED
- Device Name
- ChitoHeal Gel EUDAMED
- Model / Reference
- ChitoHeal Gel 30 g EUDAMEDchito-01 Rev.02 EUDAMEDChitoHeal Gel 60 gr EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06260455501666 EUDAMED06260455502014 EUDAMED
- Basic UDI-DI
- B-06260455501666 EUDAMEDB-06260455502014 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
ChitoHeal Gel by ChitoTech (Keifiat Tolid Takapoo) — Class III — 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-06260455501666 | 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 (2)
- EUDAMED 3f631a0e-6172-4a7e-91ed-3324dc9c5154 61 fields · synced Aug 4, 2026
- EUDAMED fc6fcbc7-e5b5-4d42-aa02-61b266454f64 61 fields · synced May 18, 2026