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DORO® Skull Clamp Radiolucent for Spinal Frames (MRI +2 more)

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 4004.101

by Black Forest Medical GmbH

Identity

Trade Name
DORO® Skull Clamp Radiolucent for Spinal Frames (MRI, CT, X-Ray and Fluoroscopy) EUDAMED
DORO® Skull Clamp FDA UDI
Generic Name
Skull clamp FDA UDI
Device Name
Headrestsystem Imaging EUDAMED
DORO® Skull Clamp Radiolucent for Spinal Frames (MRI, CT, X-Ray and Fluoroscopy) FDA UDI
Model / Reference
4004.101 EUDAMEDFDA UDI
Description
DORO® Skull Clamp Radiolucent for Spinal Frames (MRI, CT, X-Ray and Fluoroscopy) FDA UDI

Identifiers

Primary DI / UDI-DI
04250435520383 EUDAMEDFDA UDI
Basic UDI-DI
42504355PA01EH EUDAMED
Direct Marketing DI
04250435520383 EUDAMED
510(k) Number
K063494 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
Models / Variants
MRI EUDAMEDFDA UDI
CT EUDAMEDFDA UDI
X-Ray and Fluoroscopy EUDAMEDFDA 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 Safe FDA UDI

DORO® Skull Clamp Radiolucent for Spinal Frames (MRI +2 more) by Black Forest Medical GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — 3 models

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 e7f5670b-eb96-4d68-9ef3-734f3f6f5114 61 fields · synced Jul 8, 2026
  • FDA UDI c6cf4179-e406-4333-ba7f-73e9667426de 34 fields · synced May 30, 2026