Identity
- Device Name
- Impact Handle EUDAMED
- Model / Reference
- 800157 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640164282169 EUDAMED
- Basic UDI-DI
- B-07640164282169 EUDAMED
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Impact Handle by Atesos medical AG — Class IIa — 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-07640164282169 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Atesos medical AG
- EUDAMED SRN
- CH-MF-000010304
- Authorised Representative
- hestomed GmbH DE-AR-000006853
Sources (1)
- EUDAMED e183ff47-430f-4c7c-b5b0-df2c4c7f555d 61 fields · synced Jul 23, 2026