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BodyFIX Cover Sheet HIP 2000x1400 mm (5 PCS)

EUDAMEDFDA UDI

Class I (EU MDR)

Ref P10102-300

by 3C-Medical Intelligence GmbH

Identity

Trade Name
BodyFIX Cover Sheet HIP 2000x1400 mm (5 PCS) EUDAMED
BodyFIX FDA UDI
Generic Name
Vacuum-mould patient positioning system FDA UDI
Device Name
BodyFIX, BlueBAG EUDAMED
BodyFIX® Cover Sheet HIP 2000x1400mm with sleeve includes five cover sheets. The cover sheets are placed over the patient to generate the vacuum. This set is used for the BodyFIX 14 BlueBAG HIP and Total Body. FDA UDI
Model / Reference
P10102-300 EUDAMEDFDA UDI
Description
BodyFIX® Cover Sheet HIP 2000x1400mm with sleeve includes five cover sheets. The cover sheets are placed over the patient to generate the vacuum. This set is used for the BodyFIX 14 BlueBAG HIP and Total Body. FDA UDI

Identifiers

Catalog Number
P10102-300 FDA UDI
Primary DI / UDI-DI
04056719000219 EUDAMEDFDA UDI
Basic UDI-DI
04056719BUDI0000000001HU EUDAMED
Unit of Use DI
04056719002022 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
Italy EUDAMED
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

BodyFIX Cover Sheet HIP 2000x1400 mm (5 PCS) by 3C-Medical Intelligence GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID

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 bd11c716-789e-4ded-b01e-e1334817d15b 61 fields · synced Jun 19, 2026
  • FDA UDI bfe36b8f-6070-4b87-aa5a-747f1ed46eff 36 fields · synced May 30, 2026
  • EUDAMED 179c909b-ffba-489c-bafd-6783502fc02b 61 fields · synced Jun 19, 2026