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BodyFIX Comfort Module 500x400 mm

EUDAMEDFDA UDI

Class I (EU MDR)

Ref P10102-102

by 3C-Medical Intelligence GmbH

Identity

Trade Name
BodyFIX Comfort Module 500x400 mm EUDAMED
BodyFIX FDA UDI
Generic Name
Vacuum-mould patient positioning system FDA UDI
Device Name
BodyFIX, BlueBAG EUDAMED
BodyFIX® Comfort Module 500x400mm is a cushion to place the head and upper body comfortably on the couchtop where no BlueBAG is beyond the patient’s body. FDA UDI
Model / Reference
P10102-102 EUDAMEDFDA UDI
Description
BodyFIX® Comfort Module 500x400mm is a cushion to place the head and upper body comfortably on the couchtop where no BlueBAG is beyond the patient’s body. FDA UDI

Identifiers

Catalog Number
P10102-102 FDA UDI
Primary DI / UDI-DI
04056719000028 EUDAMEDFDA UDI
Basic UDI-DI
04056719BUDI0000000001HU EUDAMED
Direct Marketing DI
04056719000028 EUDAMED
510(k) Number
K121530 FDA UDI
FDA Product Code
IYE FDA UDI
EMDN Code
V0804 PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures) EUDAMED
GMDN Term
Vacuum-mould patient positioning system 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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

BodyFIX Comfort Module 500x400 mm 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 a7559ef1-31f3-4849-b768-358677779ed9 61 fields · synced Jun 19, 2026
  • FDA UDI b38426cd-ba7f-420c-b414-cb389c0029c4 35 fields · synced May 29, 2026
  • EUDAMED 49f44e00-564b-4e3b-80ac-c4e1ae1148bb 61 fields · synced Jun 19, 2026