Identity
- Trade Name
- BoneHem EUDAMED
- Device Name
- BoneHem EUDAMED
- Model / Reference
- BoneHem 3 gr EUDAMEDChito-01 Rev.02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06260455502137 EUDAMED
- Basic UDI-DI
- B-06260455502137 EUDAMED
- EMDN Code
- M040599 HAEMOSTATIC DRESSINGS - OTHER EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Poland 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
BoneHem 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-06260455502137 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- ChitoTech (Keifiat Tolid Takapoo)
- EUDAMED SRN
- IR-MF-000043341
- Authorised Representative
- CERT3GLOBAL, UNIPESSOAL, LDA. PT-AR-000037982
Sources (1)
- EUDAMED e154d456-b531-4288-a36d-d8ab7a46f78b 61 fields · synced Jun 18, 2026