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DORO LUCENT® iMRI Transfer Collision Indicator 700 MAQUET Otesus+Alphamaquet, U…

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 4003.418

by Black Forest Medical GmbH

Identity

Trade Name
DORO LUCENT® iMRI Transfer Collision Indicator 700 MAQUET Otesus+Alphamaquet, US to GE EUDAMED
DORO LUCENT® iMRI Transfer Collision Indicator FDA UDI
Generic Name
Skull clamp FDA UDI
Device Name
Headrestsystem for MR imaging EUDAMED
DORO LUCENT® iMRI Transfer Collision Indicator 700 MAQUET Otesus+Magnus, US to GE FDA UDI
Model / Reference
4003.418 EUDAMEDFDA UDI
Description
DORO LUCENT® iMRI Transfer Collision Indicator 700 MAQUET Otesus+Magnus, US to GE FDA UDI

Identifiers

Primary DI / UDI-DI
04250435534052 EUDAMEDFDA UDI
Basic UDI-DI
42504355PA05ER EUDAMED
Direct Marketing DI
04250435534052 EUDAMED
510(k) Number
K191740 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 EUDAMED
Class 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

DORO LUCENT® iMRI Transfer Collision Indicator 700 MAQUET Otesus+Alphamaquet, U… by Black Forest Medical GmbH — Class I — MDR, FDA UDI — listed in EUDAMED…

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Black Forest Medical GmbH
EUDAMED SRN
DE-MF-000005752

Sources (2)

  • EUDAMED 6e0970ea-818c-4ad7-ab3a-667bfb48403a 61 fields · synced Jul 22, 2026
  • FDA UDI 3cd53547-cbd2-46b8-966f-9d4a24965e80 34 fields · synced May 29, 2026