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BlueBAG Rectangular 1000x1000 mm/45 L

EUDAMEDFDA UDI

Class I (EU MDR)

Ref P10104-137

by 3C-Medical Intelligence GmbH

Identity

Trade Name
BlueBAG Rectangular 1000x1000 mm/45 L EUDAMED
BodyFIX FDA UDI
Generic Name
Vacuum-mould patient positioning system FDA UDI
Device Name
BodyFIX, BlueBAG EUDAMED
BlueBAG™ Rectangular 1000x1000mm/45L vacuum cushions create a comfortable, stable and precise mold of the patient’s position. FDA UDI
Model / Reference
P10104-137 EUDAMEDFDA UDI
Description
BlueBAG™ Rectangular 1000x1000mm/45L vacuum cushions create a comfortable, stable and precise mold of the patient’s position. FDA UDI

Identifiers

Catalog Number
P10104-137 FDA UDI
Primary DI / UDI-DI
04056719000561 EUDAMEDFDA UDI
Basic UDI-DI
04056719BUDI0000000001HU EUDAMED
Direct Marketing DI
04056719000561 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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

BlueBAG Rectangular 1000x1000 mm/45 L 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 52f109b5-b0f6-49e0-9ddb-39b1a660d52c 61 fields · synced Jun 19, 2026
  • FDA UDI 69a7fbed-2c84-4b01-8ee5-537e958adea3 35 fields · synced May 30, 2026
  • EUDAMED 6e876fa5-0826-4f2d-b684-6d93bd86b928 61 fields · synced Jun 19, 2026