Identity
- Trade Name
- DORO® XTom U-Belt, 3 pcs EUDAMED
- Device Name
- X-Tom Headrestsystem EUDAMED
- Model / Reference
- 4002.111 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250435535448 EUDAMED
- Basic UDI-DI
- 42504355PA07EV EUDAMED
- EMDN Code
- Z12109080 VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Orthopaedic trocar blade, reusable
DORO® XTom U-Belt, 3 pcs by Black Forest Medical GmbH — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 42504355PA07EV | Class I | Active |
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Manufacturer
- Manufacturer
- Black Forest Medical GmbH
- EUDAMED SRN
- DE-MF-000005752
Sources (1)
- EUDAMED a2f90414-dfb1-4cff-a7ba-7bc335d09c72 61 fields · synced Jun 19, 2026