Identity
- Trade Name
- DORO® XTom Torque Screwdriver EUDAMEDDORO® Torque Screwdriver FDA UDI
- Generic Name
- Skull clamp FDA UDI
- Device Name
- X-Tom Headrestsystem EUDAMEDDORO® XTom Torque Screwdriver FDA UDI
- Model / Reference
- 4002.068 EUDAMEDFDA UDI
- Description
- DORO® XTom Torque Screwdriver FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250435535349 EUDAMEDFDA UDI
- Basic UDI-DI
- 42504355PA07EV EUDAMED
- Direct Marketing DI
- 04250435535349 EUDAMED
- 510(k) Number
- K191979 FDA UDI
- FDA Product Code
- HBL FDA UDI
- EMDN Code
- Z12109080 VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Skull clamp FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4460 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
DORO® XTom Torque Screwdriver by Black Forest Medical GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 42504355PA07EV | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Black Forest Medical GmbH
- EUDAMED SRN
- DE-MF-000005752
Sources (2)
- EUDAMED e07c6227-34e1-4490-82d0-b1709a67b155 61 fields · synced Jul 9, 2026
- FDA UDI a65e24ed-6efb-4a85-8d81-9ff531f50e74 34 fields · synced May 30, 2026