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Fraxion Head Support Module ST

EUDAMEDFDA UDI

Class I (EU MDR)

Ref P10106-111

by 3C-Medical Intelligence GmbH

Identity

Trade Name
Fraxion Head Support Module ST EUDAMED
Fraxion FDA UDI
Generic Name
Stereotactic radiosurgical/radiotherapy arch head frame FDA UDI
Device Name
Fraxion EUDAMED
The FRAXION™ Head Support Module ST is the main component of the system. It provides the interface between patient immobilization components and the table top. FDA UDI
Model / Reference
P10106-111 EUDAMEDFDA UDI
Description
The FRAXION™ Head Support Module ST is the main component of the system. It provides the interface between patient immobilization components and the table top. FDA UDI

Identifiers

Catalog Number
P10106-111 FDA UDI
Primary DI / UDI-DI
04056719001414 EUDAMEDFDA UDI
Basic UDI-DI
04056719BUDI0000000002HW EUDAMED
Direct Marketing DI
04056719001414 EUDAMED
510(k) Number
K112210 FDA UDI
FDA Product Code
IYE FDA UDI
EMDN Code
V0804 PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures) EUDAMED
GMDN Term
Stereotactic radiosurgical/radiotherapy arch head frame FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
892.5050 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Fraxion Head Support Module ST by 3C-Medical Intelligence 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

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Manufacturer

Manufacturer
3C-Medical Intelligence GmbH
EUDAMED SRN
DE-MF-000023763

Sources (3)

  • EUDAMED 79ad7a98-b5c4-4bf3-8eee-925f7ad69467 61 fields · synced Jul 9, 2026
  • FDA UDI 1008ef99-ae54-4ba2-a6f7-ac19e8fa237a 35 fields · synced May 30, 2026
  • EUDAMED 42c95d1a-f294-49d7-9780-dcff0c2b4c1a 61 fields · synced Jul 9, 2026