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C-Arm Adapter Siemens Cios Spin Left

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 19154-05

by Brainlab SE

Identity

Trade Name
C-ARM ADAPTER SIEMENS CIOS SPIN LEFT EUDAMEDFDA UDI
Generic Name
Electromagnetic/optical surgical navigation device tracking system FDA UDI
Device Name
C-Arm Adapter + C-Arm Reference EUDAMED
Model / Reference
19154-05 EUDAMEDFDA UDI

Identifiers

Catalog Number
19154-05 FDA UDI
Primary DI / UDI-DI
04056481140342 EUDAMEDFDA UDI
Basic UDI-DI
4056481AdapRefJW EUDAMED
Direct Marketing DI
04056481140342 EUDAMED
510(k) Number
K183605 FDA UDI
K252562 FDA UDI
FDA Product Code
OLO FDA UDI
EMDN Code
Z12011480 SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
GMDN Term
Electromagnetic/optical surgical navigation device tracking system FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
882.4560 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

No

FDA UDI

C-Arm Adapter Siemens Cios Spin Left by Brainlab SE — 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
Brainlab SE
EUDAMED SRN
DE-MF-000006183

Sources (2)

  • EUDAMED 02ce72d7-c5db-4de4-9a63-f01dae433b51 61 fields · synced Jun 20, 2026
  • FDA UDI 26ea60c0-c4ed-4bab-8740-e69be5d6c39c 35 fields · synced May 30, 2026